Heart Care Consultants Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted by the Pennsylvania State Agency at Heart Care Consultants on 4/15/2025. The laboratory was found out of compliance with the following conditions: 493.1250 Condition: Analytic systems. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on lack of documentation, review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and interview with testing personnel (TP) #3, the laboratory failed to provide 1 of 3 API PT attestation statements for Chemistry Core testing events performed in 2023. Findings include: 1. On the day of survey, 4/15/2025, the laboratory failed to provide attestation statements for the following 1 of 3 API Chemistry Core PT events for Abbott iSTAT chemistry testing performed in 2023: - Chemistry Core 2nd Event 2023 2. TP #3 confirmed the finding above on 4/15/2025 at 10:10 am. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, lack of documentation, and interview with testing personnel (TP) #3, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed from 5/10/2023 to 6/30/2024. Refer to: 5413, 5439, and 5785 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, and interview with Testing Personnel (TP) #3, the laboratory failed to monitor and document room and refrigerator temperatures to ensure reagent stability and proper operating conditions of 1 of 1 Abbott iSTAT analyzer from 5/10/2023 to 6/30/2024. Findings include: 1. On the day of survey, 4/15/2025 at 9:30 am, review of laboratory temperature records revealed the laboratory failed to monitor and document refrigerator and room temperatures when the laboratory was closed to ensure reagent stability and proper operating conditions of 1 of 1 Abbott iSTAT analyzer used for chemistry and hematology testing for the following days from 5/10/2023 to 6/30/2024: - Refrigerator Temperature- 251of 396 days - Room Temperature- 201 of 396 days 2. TP #3 confirmed the findings above on 4/15/2025 at 9:45 am. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report -- 2 of 6 -- patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of review of policies and procedures, lack of documentation, and interview with Testing Personnel (TP )#3, the laboratory failed to perform calibration verification at least every six months for the 1 of 1 Abbott iSTAT analyzer used to chemistry examinations from 5/10/2023 to 6/30/2024. Findings include: 1. The laboratory's policy titled "Calibration and Calibration Verification" stated "CAL VER is performed: on any new, or replacement device before clinical use, every 6 months, as part of troubleshooting when controls reflect an unusual trend or consistently out of range." 2. On the date of survey, 4/15/2025 at 10:00 am, the laboratory failed to provide calibration verification records for 1 of 1 Abbott iSTAT used to perform chemistry examinations from 05/10/2023 to 06/30/2024. 3. TP #3 confirmed the finding above on 4/15/2025 at 10:30 am. D5785

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: A. Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel #5 (TP), the laboratory failed to provide 1 of 6 API PT attestation statements for routine hematology testing in 2021 and 2022. Findings Include: 1. On the day of the survey, 5/10/2023 at 10:00 am, the laboratory could not provide the following 1 of 6 API PT attestation statements for routine hematology testing in 2021 and 2022: -API Routine Hematology: 2022 Event #3 2. TP#5 confirmed the finding above on 05/10/2023 around 12:45 p.m. B. Based on review of the American Proficiency Institute (API) proficiency records and interview with testing personnel #5 (TP), the laboratory failed to provide 3 of 6 PT attestation statements for routine chemistry testing and 1 of 6 PT attestation statements for routine hematology testing signed by the laboratory director or designee in 2021 and 2022. Findings include: 1. On the day of the survey, 05/10/2023 at 10:00 am, the following API PT attestation statements were not signed by the laboratory director or designee in 2021 and 2022. - Routine Chemistry: i-STAT Chemistry : - 2021 Event #3. - 2022 Event #2 - 2022 Event # 3 -Routine Hematology: 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 -- i-STAT Hematology -2022 Event 2 2. TP #5 confirmed the findings above on 05/10 /2023 around 12:45 pm. 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 review of test requisitions and interview with testing personnel #5 (TP), the laboratory failed to include the address of the authorized person requesting routine hematology and chemistry testing from 04/02/2021 to date of the survey. Findings Included: 1. On the day of survey, 05/10/2023 at 11:30 am, review of 1 of 1 patient test requisitions revealed that the test requisition did not include the address of the authorized person requesting routine hematology and chemistry testing from 04/02 /2021 to 05/10/2023. 2. TP#5 confirmed the above finding on 05/10/2023 around 12: 45 pm. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with testing personnel #5 (TP), the laboratory failed to perform calibration verification at least once every six months as required for 1 of 1 Abbott iSTAT analyzer used for routine chemistry testing from 04 /02/2021 to the date of the survey. Findings include: 1. On the date of the survey, 05 /10/2023 at 11:23 am, the laboratory could not provide calibration verification records for the required analytes tested on 1 of 1 Abbott iSTAT analyzer used for routine chemistry testing from 04/02/2021 to 05/10/2023. 2.TP #5 confirmed the findings above on 05/10/2023 around 12:45 pm. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with testing personnel #5 (TP), the laboratory failed to include pertinent reference intervals/normal values on patient test reports for routine chemistry and hematology examinations performed on the Abbott iStat analyzer from 04/02/2021 to the date of survey. Findings Include: 1. On the date of the survey, 05/10/2023 at 11:30 am, review of 1 of 1 patient test reports revealed that the final patient test reports did not include reference ranges/normal values for routine chemistry and hematology testing performed on the Abbott iSTAT analyzer from 04/02/2021 to 05/10/2023 . 2.TP#5 confirmed the finding above on 05 /11/2023 around 12:45 pm. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the technical consultant (TC), the laboratory failed to establish a maintenance and function check protocol for 2 of 2 unlabelled thermometers used to monitor Abbott istat cartridges and reagents stored in the refrigerator and room temperature the from 04/11/2019 to 04/02/2021. Findings include: 1. On the day of survey, 04/02/2021, the surveyor observed 1 of 1 unlabeled refrigerator thermometer and 1 of 1 La Crosse Technology room temperature thermometer in use to monitor the temperatures of Abbott istat cartridges and reagents used on the Abbott istat. 2. The laboratory could not provide a maintenance and function check protocols or documentation of maintenance and function performed on of 1 unlabeled refrigerator thermometer and 1 of 1 La Crosse Technology room temperature thermometer from 04/11/2019 to 04/02/2021. 3. The TC confirmed the findings above on 04/02/2021 around 11:50 am. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manuals and interview with the technical consultant (TC), the laboratory director (LD) failed to follow laboratory procedures and perform yearly technical consultant (TC) competency assessment in 2019, 2020 and 2021. Findings include: 1. The Laboratory Competency Assessment Policy states, "Competency assessment of the technical consultant will be done by the laboratory director". 2. On the day of survey, 04/02/2021, the TC could not provide their competency assessment documentation from 2019, 2020 and 2021. 3. The TC confirmed on 4/02/2021 around 10:15 am, they were not assessed for competency by the LD. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 record review and interview with Testing Personnel (TP) #1 on 04/11/19, the Laboratory failed to have a written or electronic laboratory test request form for all patient testing for an ordering provider from 12/10/18 to the date of the survey. Findings Include: 1. During the time of the survey, 04/11/19 at 12:00 pm, TP #1 could not provide evidence of test requisition (written or electronic) forms and could not show how many patients Activating Clotting Time (ACT) were requested from an ordering provider. 2. The TP #1 confirmed the above findings, 04/11/19 at 12:00 pm. 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)