Scranton Hematology Oncology

Summary Statement of Deficiencies 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 Medical Technologist (MT), the laboratory failed to perform the twice annual verification of accuracy for Manual Reticulocyte (hematology) microscopic examinations for 1 of 1 year (2024). Findings Include: 1. On the day of survey, 01/13/2026 at 09:45 am, the laboratory could not provide documentation for 1 of 2 annual verification of accuracy for Manual Reticulocyte (hematology) microscopic testing performed for 1 of 1 year (2024). 2. The laboratory performed 41 manual reticuloctye (hematology) microscopic examinations in 2024. 3. The MT confirmed the findings above on 01/13/2026 at 10: 45 am. *** Repeat Deficiency*** 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. 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 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Medical Technologist (MT), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 Virtual Diagnostics Envoy 500 Chemistry analyzer and 2 of 2 Abbott Cell Dyn Emerald hematology analyzers from 2/15/2024 to date of survey. Findings include: 1. Review of Abbott's operating conditions for Cell Dyn Emerald suggested less than 80% Relative Humidity and Virtual Diagnostics' operating conditions for the Envoy 500 has a suggested Relative humidity of 10 to 90%. 2. On the day of the survey, 01/13/2026 at 10:30 am, the laboratory failed to provide documentation for the monitoring of room humidity to ensure operating conditions were met for the following when chemistry and hematology testing was performed from 02/15/2024 to 01/13/2026: -1 of 1 Virtual Diagnostic Envoy 500 Chemistry Analyzer - 2 of 2 Abbott Cell Dyn Emerald Hematology Analyzers 3. The laboratory performed 10,343 chemistry and hematology tests in 2025 (CMS 116, estimated annual volume, dated 01/13/2026). 4. The MT confirmed the above findings on 1/13/2026 at 10:30am. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

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: Based on review of College of American Pathologist (CAP), American Proficiency Institute (API) proficiency testing (PT) records, and interview with the technical supervisor #1 (TS#1), the laboratory failed to provide 2 of 6 CAP and 4 of 6 API PT attestation statements signed by the laboratory director in 2022 and 2023. Findings Include: 1. On the day of survey, 02/15/2024, review of CAP and API PT records revealed the following PT attestation statements were not signed by the laboratory director in 2022 and 2023: Hematology - 2022 CAP Hematology Automated Differential- FH1-A and FH1-C Chemistry - 2022 API Chemistry Core Events #1, #2 and #3 - 2023 API Chemistry Core Event # 1 2. TS #1 confirmed the findings above on 02/15/2024 at 12:55 pm. *Repeat Deficiency D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the technical supervisor #1 (TS#1), the laboratory failed to establish a procedure to assess the competency of their testing personnel (TP), general supervisor (GS), and technical supervisor (TS) for their responsibilities in 2022 and 2023. Findings include: 1. On the day of survey, 2/15 /2024 at 01:24 pm, the laboratory failed to provide a procedure to assess the competency of TS, GS, and testing personnel (CMS 209 personnel 1, 2, and 3) for their responsibilities in 2022 and 2023. 2. The laboratory failed to provide competency assessment records for the following 1 of 1 GS, and 1 of 1 TS (personnel #1 on CMS 209) for their supervisory responsibilities from 03/08/2022 to the date of survey. 3. TS #1 confirmed the findings above on 02/15/2024 around 01:24 pm. *Repeat Deficiency 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 supervisor #1 (TS#1), the laboratory failed to perform the twice annual verification of accuracy for Manual Reticulocyte (hematology) microscopic examinations from 3/08/2022 through the date of survey. Findings Include: 1. On the day of survey, 02/15/24 at 01:45 pm, the laboratory could not provide documentation of twice annual verification of accuracy for Manual Reticulocyte (hematology) microscopic testing from 03/08/2022 to 02/15/2024. 2. TS #1 confirmed the findings above on 2/15/2024 at 1:45pm. 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 lack of documentation and interview with the technical supervisor #1 -- 2 of 5 -- (TS#1), the laboratory failed to provide test requisitions for hematology and chemistry tests performed from 03/08/2022 through day of survey. Findings Included: 1. On the day of survey 02/15/2024 at 03:06 pm, the laboratory failed to provide patient test requisitions with the required information for hematology and chemistry testing performed from 3/08/2022 through day of survey. 2. TS #1 confirmed the above finding on 02/15/2024 at 3:06 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 review of the Envoy 500 chemistry analyzer calibration verification (CV) records and interview with technical supervisor #1 (TS#1), the laboratory failed to perform CV for 18 of 18 analytes on the Envoy 500 analyzer at least every 6 months from 08/30/2022 to 07/25/2023. Findings include: 1. On the day of the survey, 02/15 /2024 at 01:59 pm, the laboratory failed to provide documentation of CV on the Envoy 500 analyzer for the following analytes at least every 6 months: Envoy 500 - Albumin -Alkaline Phosphatase (ALP) -Alanine aminotransferase (ALT) -Aspatartate aminotransferase (AST) -Blood urea nitrogen (BUN) -Bilirubin, Direct -Bilirubin, Total -Calcium -Chloride -Sodium -Potassium -Carbon dioxide (CO2) -Creatinine - Glucose -Lactate dehydorgenase (LDH) -Magnesium -Protein, total -Uric acid 2. The laboratory performed CV on 8/30/2022 and 7/25/2023. 3. The laboratory performed 26,723 chemistry examinations in 2023 (annual volume listed on CMS 116 form). 4. TS #1 confirmed the findings above on 02/15/2024 at 01:59 pm. 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 -- 3 of 5 -- concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manual reticulocyte quality control documentation, review of patients results and interview with technical supervisor #1 (TS #1), the laboratory failed to perform quality control at least once a day before reporting manual reticulocyte results from 3/08/2022 to the day of survey. Findings include: 1. On the day of survey 02/15/2024 at 02:17 pm, review of the laboratory's Reticulocyte Count policy stated, "on every day that a reticulocyte count is ordered on a patient, choose two levels of Retic-chex control." 2. Review of the patient Reticulocyte log revealed the laboratory failed to include two control materials of different concentrations before resulting patient results from 03/08/2022 to 02/15/2024. 3. TS #1 confirmed the above findings on 02/15/2024 at 02:17 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 supervisor #1 (TS#1), the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instrumentation in hematology from 03/08/2022 to the date of the survey. Findings include: 1. On the date of the survey, 02/15/2024 at 01:54 pm, the laboratory failed to provide documentation of the biannual comparison studies for the following 2 of 2 tests performed from 03/08/2022 to 02/15/2024: - Cell Dyn Emerald Serial Number 10040 (CBC with Auto Differential) v. Cell Dyn Emerald Serial Number 10042 (CBC with Auto Differential) - Manual white blood cell differentials vs. automated white blood cell differentials (Cell Dyn Emerald) 2. TS #1 confirmed the above findings on 02/15/2024 at 01:54 pm. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of documentation, review of the laboratory's quality assurance (QA) procedure, and interview with technical supervisor #1 (TS #1), the Laboratory Director (LD) failed to ensure a QA program was established and maintained to ensure the quality of services provided by the laboratory from 03/08/2022 to the date of survey. Findings include: 1. Review of the laboratory's Quality Assurance policy states, "the laboratory director oversees the implementation of the QA plan and helps identify and correct problems as they occur. The QA plan is periodically reviewed to -- 4 of 5 -- minimize the possibility of recurrence of problems. When problems are identified, areas for improvement to the QA plan may be implemented. Qualitiy Assurance includes the following components: *Personnel Training and Qualifications, *Proficiency Testing, *Procedure Manual, *Specimen Collection and Handling Specifications, *Patient Test Management/Record Keeping, *Quality Control Program, * Instrument Maintenance Program, * Laboratory Safety. As necessary, revise your Quality Assurance based on the results of the monthly evaluations." 2. On the date of survey, 02/15/2024 at 02:30 pm, the laboratory failed to provide documentation for the periodic QA evaluation performed to assess the laboratory's pre- analytical, analytical, and post-analytical processes from 03/08/2022 to 02/15/2024. 3. TS #1 confirmed the findings above on 02/15/2024 at 02:30 pm. -- 5 of 5 --

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: Based on lack of documentation and interview with Testing Personnel (TP) #2, the laboratory failed to provide 6 of 6 American Proficiency Institute (API) and 2 of 3 College of American Pathologist(CAP) proficiency testing (PT) attestation statements for chemistry and hematology in 2020 and 2021. Findings Include: 1. On the day of survey, 03/08/2022 at 09:33 am, the laboratory did not provide the following API an CAP PT attestation statements in 2020 and 2021 a. API Chemistry Core: - 2020 Event #1, Event #2, Event #3. - 2021 Event #1, Event #3. b. CAP Hematology: - 2021 Event B. 2. The following API and CAP PT attestation statements were not signed by the Testing personnel and the laboratory director/designee in 2021. a. API Chemistry Core: - 2021 Event #2. b. CAP Hematology: - 2021 Event C 3. TP#2 confirmed the findings above on 03/08/2022 around 11:20 a.m. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 competency assessment records, review of the laboratory procedure manual, and interview with the Testing Personnel (TP)#2, the laboratory failed to follow their competency assessment procedure and assess the competency assessment of 1 of 1 Technical Supervisors (TS), 1 of 1 General Supervisor (GS) for their supervisory responsibilities and 4 of 4 Testing Personnel (TP) for manual differentials from 03/08/2020 to 03/08/2022. Findings Include: 1. On the day of survey 03/08/2022 at 10:14 a.m, The TP#2 could not provide competency assessment records for 1 of 1 TS and 1 of 1 GS for their supervisory responsibilities in 2020 and 2021. 2 The laboratory could not provide competency assessment records with the six components required by CLIA for 4 of 4 TP who performed manual differentials in 2020 and 2021. 2. The TP#2 confirmed the findings above on 03/08 /2022 at 11:20 a.m. * Repeated deficiency. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based a review of proficiency testing records and interview with the testing personnel (TP)#2, the Laboratory failed to review and evaluate the results obtained on proficiency testing for 1 of 3 American Proficiency Institute (API) and 3 of 6 College of American Pathologist (CAP) for Chemistry and Hematology in 2020 and 2021. Findings: 1. On the day of survey, 03/08/2022 at 09:50 a.m., the records reviewed revealed that the laboratory could not provide records of the evaluation and review of the following: a. API Chemistry: 2020 event#1 b. CAP Hematology: 2020 Event A, Event C, and 2021 Event C 2. The TP#2 confirmed the findings above on 03/08/2022 around 11:20 a.m. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of Quality Assurance (QA) documentation and interview with the testing personnel (TP)#2, the Laboratory Director (LD) failed to ensure a QA program, was established, and maintained to ensure the quality of services provided by the laboratory from 03/08/2020 to 03/08/2022. Findings include: 1. On the day of survey 3/08/2022 at 11:05 a.m, the laboratory could not provide QA records. 2. The -- 2 of 3 -- laboratory performed 48,526 non waived tests in the last year according to CMS-116 submitted by the laboratory. 3. The TP#2 confirmed there were no QA record on 03/08 /2022 at 11:20 a.m. * Repeated Deficiency -- 3 of 3 --

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 procedure manuals and interview with technical supervisor (TS), the laboratory failed to establish a complete procedure to assess the competency of 4 of 4 TP who performed manual differential examinations, complete blood count (CBC) and complete metabolic panel (CMP) tests and 1 of 1 clinical consultant competency in 2018 and 2019. Findings include: 1. On the day of survey, 10/29/2019, the laboratory failed to provide a complete written policy to assess the competency of 4 of 4 TP for each type of testing (manual differential examinations, CBC and CMP) and 1 of 1 clinical consultant competency from 2018 and 2019. 2. The TS confirmed the findings above on 10/29/2019 around 08:55 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on, the review of records, observation of laboratory thermometers and interview with the technical supervisor (TS), the laboratory failed perform the maintenance/ calibration of 1 of 1 laboratory refrigerator and 1 of 1 freezer from 2017 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 -- to the date of survey. Findings Include: 1. On the date of survey, 10/29/2019, while on tour of the laboratory, the surveyor observed 1 of 1 Fisher Scientific Traceable thermometer (refrigerator), S/N#150803434 was due for maintenance / calibration on 10/26/2017 and 1 of 1 Acu-Rite thermometer (Freezer) did not state the last maintenance or calibration date. 2. The laboratory could not provide documentation of last calibrations/ maintenance for both thermometers that house reagents for the Evoy 500 chemistry analyzer and the Abbot Cell Dyn- Emerald hematology analyzer. 3. The TS confirmed the findings above on 10/29/2019 around 11:00 am. 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 review of the Envoy 500 chemistry analyzer records and interview with the technical supervisor (TS), the laboratory failed to evaluate the relationship between 2 of 2 Abbott Cell Dyn Emerald hematology analyzers in 2018. Findings Include: 1. On the day of survey, 10/29/2019, the TS could not provide documentation of comparison studies performed on 2 of 2 Abbott Cell Dyn Emerald hematology analyzers in 2018 2. The TS confirmed the finding above on 10/29/2019 around 10:50 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on, the review of laboratory quality assurance procedure, quality assurance records and interview with technical supervisor (TS), the laboratory failed to ensure that quality assessment programs are documented to assure the quality of laboratory from December 2017 to the date of survey. Findings Include: 1. The Quality Assurance procedure states "revise your quality assurance program on the result of the monthly evaluations.." 2. On the day of survey, 10/29/2019, the laboratory could not provide documentation of monthly quality assessment activities performed form December 2017 to September 2019. 3. The TS confirmed the findings above, on 10/29 /19 around 9:15 am. *** Repeat Deficiency*** D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the competency assessment records, proficiency testing (PT) records and interview with the Technical Supervisor (TS), the TS failed to assess 1 of 4 TP for test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples, who performed manual differential, Complete blood count (CBC) and complete metabolic panel (CMP) tests in 2018 and 2019. Findings include: 1. On the day of survey, 10/29/2019, review of PT records and TP competency assessment records revealed, the assessment of external proficiency testing samples was not performed for 1 of 4 TP who performed manual differential, CBC and CMP tests in 2018 and 2019. 2. The following personnel were not assessed for test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples: - In 2018 Hematology, TP#1 - In 2018 Chemistry, TP#2 - In 2019 Hematology, TP#1 - In 2019 Chemistry, TP#3 3. The TS confirmed the finding above on 10/29/2019 around 9:50 am. . -- 3 of 3 --