Pottsville Cancer Clinic

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) (b)The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with Testing Personnel (TP) # 1 (CMS 209 personnel # 2), the laboratory failed to examine 6 of 6 API PT hematology /coagulation testing events in the same manner as patient specimens in 2023 and 2024. Findings include: 1. On the day of survey, 01/15/2025 at 1:19 pm, review of the laboratory's API PT records revealed the laboratory failed to examine the following API hematology/coagulation PT samples in the same manner as patient specimens for 6 of 6 API PT testing events in 2023 and 2024: - Complete blood count (CBC) with 3- part white blood cell differential (HSY 01-HSY 05, HSY 06-HSY 10, HSY 11-HSY 15). 2. Interview with TP # 1 on 01/15/2025 at 1:30 pm confirmed the PT samples for CBC were analyzed by two different testing personnel (CMS 209 personnel #2 and #3) and the final result reported was based on the calculated average. 3. The laboratory could not provide documentation stating the CBC testing was included in the laboratory's patient repeat criteria. 4. TP # 1 confirmed the findings above on 01/15 /2025 at 2:31 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 --

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 review of the laboratory personnel report (CMS-209), personnel credentials, competency assessment (CA) records, and interview with testing personnel #1 (TP), the technical consultant (TC) failed to evaluate the competency of 3 of 4 testing personnel (TP) that performed hematology testing in 2022. Findings include: 1. Review of the CMS 209 personnel form, signed by the laboratory director (LD) on 06 /13/2023, lists the LD as the only TC. 2. Further review of CA records and interview with TP #1 on 06/13/2023 at 01:46 pm, revealed that TP #1 performed the competency assessments for 3 of 4 TP (CMS 209 TP #2, #3, and #4) that performed complete blood cell counts on the Medonic hematology analyzer in 2022. 3. Review of personnel credentials provided on the date of the survey, revealed TP #1 has a high school diploma, which does not meet the minimum educational qualifications (493.1411) to perform technical consultant responsibilities for moderate complexity testing in hematology. 4. TP #1 confirmed the findings above on 06/13/2023 around 3: 00 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 --

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 the laboratory's procedure manuals , review of testing personnel records and interview with testing personnel (TP) #1, the laboratory failed to establish a complete competency assessment procedure to assess new TP (1 of 4) for competency in 2019. Findings include: 1. On the day of survey, 05/27/2021, TP#1 could not provide a complete competency assessment procedure to assess testing personnel for competency at least semiannually during the first year the individual tests patient specimens. 2. TP#4 was assessed for competency on December 2019 and again in December 2020. 3. TP#1 confirmed TP#4 was not assessed semiannually in 2019 on 05/27/2021 around 9:30 am. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Clinical Diagnostics Solutions (CDS) M series M32 complete blood count (CBC) analyzer procedure, validation records and interview with testing personnel (TP) #1, the laboratory director (LD) failed to approve, sign, and date the new CBC analyzer procedure and validation study before testing began in 2019. 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 -- Findings include: 1. On the day of survey, 05/27/2021, review of the CDS M series M32 CBC analyzer procedure and validation study revealed, the current laboratory director did not sign the forms before testing began on May 2019. 2. On the day of survey, 05/27/2021, the LD signed the procedure and instrument validation around 11: 45 am. 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 testing personnel (TP) #1, the laboratory failed to establish a maintenance policy to assess the maintenance /function for 2 of 2 thermometers used to monitor the temperatures of reagents used on Clinical Diagnostics Solutions (CDS) M series M32 complete blood count (CBC) analyzer from 2019 to the day of survey. Findings Include: 1. On the day of survey, 05 /27/2021, the surveyor observed 1 of 1 unlabeled mercury refrigerator thermometer and 1 of 1 Ortho Biotech clock/thermometer used to monitor the temperature of reagents stored at room temperature for the CDS M series M32 CBC analyzer. 2. The laboratory could not provide documentation of maintenance/function checks performed on 2 of 2 thermometers. 3. The laboratory could not provide a maintenance policy for the thermometers. 4. TP #1 confirmed the findings above on 05/27/2021 around 11:45 am. D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interview with the testing personnel (TP) #1, the laboratory director (LD) failed to assure that quality assessment programs were maintained from May 2019 to April 2021. Findings include: 1. On the day of survey, 05/27/2021, review of the daily log sheet revealed, 24 of 24 daily log sheets were not reviewed or signed by the LD from May 2019 to April 2021. 2. In 2019 - 3 of 8 months of daily log sheets were not reviewed. 3. In 2021 - 4 of 4 months of daily log sheets were not reviewed. 4. From May 2019 to April 2021, the following daily log -- 2 of 3 -- sheets were reviewed by TP#1, which is not listed as a technical consultant. - 2019: 5 of 8 months. - 2020: 12 of 12 months. 5. TP #1 and the LD confirmed the findings above on 05/27/2021 around 11:50 pm. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of testing personnel records and interview with testing personnel (TP) #1 the laboratory director failed to ensure that prior to testing patients specimens, 1 of 4 TP received the appropriate training for performing complete blood count (CBC) tests in 2019. Findings include: 1. On the day of survey, 05/27/2021, TP#1 could not provide the training records for TP#4 performing CBC tests from December 2019 to May 27, 2021. 2. TP#1 confirmed the finding above on 05/27/2021 around 9: 30 am. -- 3 of 3 --

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 performance evaluations from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: White Blood Cell Differential (WBC Diff) in the specialty of hematology. The laboratory had unsatisfactory scores for the 2nd event of 2019 and the 3rd event of 2019. See D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive 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 Report 155 report and performance evaluations from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: White Blood Cell Differential (WBC Diff) in the specialty of hematology. The laboratory had unsatisfactory scores for the 2nd event of 2019 and the 3rd event of 2019. Findings include: 1. API 2019 Event 2 - WBC Diff score was 67%. 2. API 2019 Event 3 - WBC Diff score was 60%. -- 2 of 2 --

Summary Statement of Deficiencies D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on, the review of personnel competency assessment records, American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1, the Technical Consultant failed to assess the competency of 3 of 4 TP through internal blind testing samples or external PT samples for Complete Blood Count (CBC) from 2017 to the date of survey. Findings Include: 1. On the day of survey, 10/18/2018, review of competency assessment records revealed the laboratory did not assess the test performance of 3 of 4 TP through internal blind testing samples or external PT samples for: - API CBC PT events #2 and #3 in 2017. - API CBC PT events #1 and #2 in 2018. 2. TP #1 was the only personnel performing yearly PT evaluations. 3. TP#1 confirmed the findings above on 10/18/2018 around 10:20 am. 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 --