Rothman Orthopaedic Specialty Hospital Lab

Summary Statement of Deficiencies 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: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) records and interview with the laboratory director (LD), the LD/designee failed to sign 1 of 3 CAP PT attestation statement documents for chemistry testing performed in 2022. Findings Include: 1. On the day of the survey, 09/19/2023 at 10:15 am, review of the CAP PT records revealed that the following 1 of 3 CAP PT attestation statements reviewed were not signed by the LD or designee in 2022: - Critical Care Blood Gas with Chemistry, i-STAT Survey: AQI-B 2022 2. The LD confirmed the findings above on 09/19/2023 at 02:00 pm. 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 record review and interview with technical consultant #2 (TC), the laboratory failed to ensure that the State of Pennsylvania (PA) regulations were met regarding having a supervisor on site during all normal scheduled working hours in which tests were performed from 09/20/2022 through the day of survey. Findings include: 1. The PA regulation (5.23(b)(1) states: "A general supervisor who meets all 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 -- the requirements of subsection (a)(1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed." 2. On the day of the survey, 09/19/2023 at 10:30 am, further review of the laboratory personnel report (PA State), and personnel credentials revealed the laboratory failed to ensure the PA regulations were met regarding having a quailifed supervisor on site during all normal scheduled working hours in which tests were performed from 09/20 /2022 to 09/19/2023. 3. Review of the CMS 116 revealed the laboratory performs patient testing 7 days a week, 24 hours a day. 4. TC #2 confirmed the findings above on 09/19/2023 at 02:00 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. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical consultant #2 (TC), the laboratory failed to perform calibration verification at least once every six months for 4 of 4 Abbott iSTAT analyzers from 09/23/2022 to the date of the survey. Findings include: 1. On the date of the survey, 09/19/2023 at 01:19 pm, the laboratory could not provide calibration verification records for the required analytes tested on 4 of 4 Abbott iSTAT analyzers from 09/23/2022 to 09/19/2023. 2. TC #2 confirmed the finding above on 09/19/2023 at 02:00 pm. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical consultant #2 (TC), the laboratory failed to inspect the alarm system for 1 of 1 refrigerator used for storage of blood products to ensure an audible alarm was activated at the appropriate temperatures from 09/23/2022 to the date of the survey. Findings Include: 1. On day of survey, 09/19/2023 at 09:47 am, the laboratory could not provide an established policy for inspecting the alarm system for 1 of 1 refrigerator used for storage of blood products to ensure an audible alarm was activated at the appropriate temperatures from 09/23/2022 to 09/19/2023. 2. The laboratory could not provide documentation of the alarm checks performed for 1 of 1 refrigerator from 09/23/2022 to 09/19/2023. 3. TC #2 confirmed the findings above on 09/19/2023 at 02:00 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical consultant #2 (TC), the laboratory failed to have a system that twice a year evaluates the relationship between 4 of 4 Abbott iSTAT analyzers used for chemistry and hematolgy testing from 09/23 /2022 to the day of the survey. Findings include: 1. On the day of the survey, 09/19 /2023 at 11:00 am, the laboratory could not provide documentation of the biannual comparison of test results for 4 of 4 Abbott iSTAT analyzers used for chemistry and hematology testing from 09/23/2022 to 09/19/2023. 3. The laboratory performed 712 hematology examinations and 5,696 chemistry examinations in 2022 (CMS-116 annual volume). 4. TC #2 confirmed the findings above on 09/19/2023 at 02:00 pm. D6022 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 the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records, lack of documentation, and interview with technical consultant #2 (TC), the laboratory director (LD) failed to ensure that quality control (QC) and quality assessment (QA) programs were established and maintained to identify failures in quality as they occur from 09/23 /2022 to the date of the survey. Findings Include: 1. On the day of the survey, 09/19 /2023 at 12:13 pm, the laboratory could not provide documentation of the QA activities performed to assure the quality of laboratory (preanalytical, analytical, and -- 3 of 4 -- postanalytical) services from 09/23/2022 to 09/19/2023. 2. Further review of the laboratory's QC records revealed that