Lancaster Cancer Center Ltd

Summary Statement of Deficiencies D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on lack of documentation, review of laboratory procedures, and interview with the Technical Consultant (TC), the laboratory failed to establish and maintain a policy to ensure all complaints and problems reported to the laboratory are documented and investigated when needed from 02/23/2023 to the day of survey. Findings include: 1. On the day of survey, 11/13/2024 at 1:00 pm, the laboratory could not provide a policy to ensure all complaints and problems reported to the laboratory were documented and investigated as needed from 02/23/2023 to 11/13/2024. 2. The TC confirmed the finding above on 11/30/2024 at 01:00 pm. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical Consultant (TC), the laboratory failed to ensure the verification of accuracy for Reticulocyte Hemoglobin (Ret-He) examinations were performed at least twice annually in 2023. Findings include: 1. The laboratory's Reticulocyte Hemoglobin Comparison policy states" Every 6 months we perform a comparison with the local hospital (Lancaster 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 -- General Hospital - LGH) to compare our reticulocyte hemoglobin's (RET-He). The Ret-He is first run on the Sysmex XN-450, and then the specimen is sent to LGH for comparison on the Sysmex XN-10." 2. On the day of survey, 11/13/2024, the laboratory failed to provide documentation that the verification of accuracy of Ret-He examinations performed on the Sysmex XN-10 was performed at least twice annually in 2023. 3. The TC confirmed the findings above on 11/13/2024 at 10:45 am. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to establish a complete written procedure to ensure the reference laboratory's instructions for specimen referral were followed from 02/23/2023 to the date of the survey. Findings include: 1. The laboratory's Send out Policy states "When our physicians order testing that we do not perform in house, the samples are collected by the lab personnel and sent to the hospital via courier. There are 2 pickup times, 10:45 am and 03:00 pm". 2.On the date of the survey, 11/13/2024, review of the laboratory's procedures revealed the laboratory failed to include the following in the Send Out policy to ensure the reference laboratory's instructions for specimen referral were followed from 02/23 /2023 to 11/13/2024: - Specimen storage and preservation - Specimen processing 3. The laboratory failed to provide a current service manual for 1 of 1 reference laboratory (Lancaster General Hospital) that patient specimens are referred to. 4. The TC confirmed the above findings on 11/13/2024 at 11:30 am. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, operator manuals, and interview with the Technical Consultant (TC), the laboratory failed to have a complete written procedure manual for chemistry testing performed that met the requirements of 493.1251 from 02/23/2023 to the date of the survey. Findings include: 1. On the day of the survey, 11/13/2024 at 11:30 am, review of the procedure manuals for chemistry testing revealed the operators manuals were used to perform testing on 1 of 1 Beckman Coulter AU680 chemistry analyzer from 02/23/2023 to 11/13/2024: 2. Review of the operators manual revealed that the test system instructions used failed to include the following requirements of 493.1251 that are specific to the laboratory: - -- 2 of 6 -- Step by step performance of the procedure including test calculations and interpretation of results - Preparation of slides, solution, calibrators, controls, reagents, stains, and other material used in testing. - Control procedures - Calibration and calibration verification procedures. -

Summary Statement of Deficiencies 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 laboratory's competency policy and interview with the Technical Consultant (TC), the laboratory failed to follow their procedure to assess the competency of the technical consultant (on the CMS 209 form, listed as personnel #2) for their regulatory responsibilities in 2021 and 2022. Findings include: 1. The laboratory's competency policy states: "Staff who hold CLIA Supervisor positions (General Supervisor, Technical Supervisor, or Clinical Consultant) will be assessed annually for their supervisory competence in addition to laboratory testing competence, if performing any lab testing. 2. On the day of survey, 02/22/2023 at 09: 30am. The laboratory could not provide a competency assessment for 1 of 1 technical consultant (TC) for their regulatory responsibilities in 2021 and 2022. 3. The laboratory could not provide a delegation of duties from the laboratory director to 1 of 1 TC. 4. The TC confirmed the finding above on 02/22/2023 around 11:30am. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte Prothrombin Time (PT). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte: Prothrombin Time (PT). The laboratory had unsatisfactory scores for the 1st event of 2022, and 2nd event 2022. Findings include: Analyte Year Event Score PT 2022 1 60% PT 2022 2 60% -- 2 of 2 --

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on laboratory personnel interview and review of the laboratory Testing Personnel records on the date of the survey (02/16/2021), the Technical Consultant failed to assure the staff maintained competency for 2 of 2 testing personnel. Findings include: 1. Review of the laboratory Testing Personnel records revealed no platforms were stated in competency records for 2 of 2 Testing Personnel who performed Chemistry and Hematology tests from 08/16/2018 through the date of the survey. 2. The Laboratory Director acted as the Technical Consultant from 08/16/2018 to date of the survey. 3. During the survey at 11:00 pm, the senior Testing Personnel confirmed the above findings. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 surveyor observation of the laboratory, review of laboratory room temperature records and interview with the Technical Consultant (TC), the laboratory failed to monitor and document the room temperature where the Beckman Coulter Access 2 ISE solutions (13 of 13 Bottles) are stored from 2017 to the date of survey. Findings include: 1. On the day of survey, 08/16/2018, while on the tour of the laboratory, it was discovered that the room where the Beckman Coulter Access and its solutions are stored, the room temperature is not monitored. 2. Review of the ISE solution labels, revealed they need to be kept between the temperature of 2 degrees to 25 degrees Celsius. 3. The Cabinet in the room stored: - 4 of 4 bottles of ISE Mild Standard Solution, Lot# M802042 - 6 of 6 bottles of ISE Buffer Solution, Lot# M803095 - 3 of 3 bottles of ISE Reference Solution, Lot #M707082 4. The TC confirmed the findings above on 08/16/2018 around 11:00 am. 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 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 -- 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 review of Beckman Coulter AU480 Analyzers calibration verification (CV) records and interview with Technical Consultant (TC), the laboratory failed to perform CV on the Beckman Coulter AU480 Analyzer at least every 6 months. Findings include: 1. On the day of survey, 08/16/2018, review of Beckman Coulter AU480 Analyzer CV records, revealed that the laboratory performed CV on 12/27 /2017 and again on 07/22/2018, which is outside of the six-month time schedule (should have been performed no later than 06/27/2018). 2. The TC confirmed the finding above on 08/16/2018 around 10:30 am. 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