Heartland Pathology, Pa

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 the review of the cytology procedure manual, lack of current laboratory director (LD) approval and interview with the cytology general supervisor (CT/GS), the laboratory failed to have 19 of 47 cytology procedures approved, signed, and dated by the current laboratory director before use. Findings: 1. Review of the laboratory cytology procedures revealed the current LD did not approve, sign, and date 19 of 47 of the laboratory procedures at the time of survey. 2. The following procedures were not signed by the current LD: a. Pathologist Qualifications. b. Quality Assurance Program. c. QA Program for Heartland Pathology Pathologists. d. Maintaining Proper Quality Assurance During the Pre-analytical, Analytical and Post- analytical Phases. e. Imminently Life=Threating Test Results Significant and Unexpected Findings. f. Specimen Rejection Procedure. g. Cytology Microscope Evaluation. h. Course of Action When the Novopath System or Server Becomes Inoperable (Fail-Safe). i. Cytopathologic Interlaboratory Comparison Program. j. Cytology Workload Limits Primary Screening. k. Non-Gynecologic Specimens with a High Potential for Cross-Contamination. l. Collection and Receipt of Specimens. m. Esophageal Brushings. n. Gastric Washing & Brushings. o. Fine Needle Aspiration - General. p. Fine Needle Aspiration - Thyroid. q. Fine Needle Aspiration - Breast. r. Cell Block Preparation. s. Interpreting Results and Reporting on Non Gyn Cytology Cases. 3. Interview with the CT/GS on 1/16/25at 11:50 a.m. confirmed, the laboratory failed to have 19 of 47 cytology procedures approved, signed, and dated by the current laboratory director before use. D5775 COMPARISON OF TEST RESULTS 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 -- 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. This STANDARD is not met as evidenced by: Based on the review of the CMS-116 test lists, tour of the laboratory, lack of comparison study documents, and interview with the Director of Laboratory Services (DLS), the laboratory failed to perform comparison studies on Immuno Histochemical (IHC) stains performed on three of three Ventana Benchmark staining instruments for 2023, 2024, and to date of survey 2025. Findings: 1. Review of the CMS116 test lists revealed that 77 IHC stains are performed in the laboratory. 2. During a tour of the laboratory, the surveyor noted that the IHC stains are performed by three Ventana Benchmark staining instruments. Serial numbers are 319259, 319258, 320951. All three instruments can perform all 77 stains. 2. The surveyor requested documentation of twice a year comparisons of the 77 stains on the three Ventana Benchmark instruments. No documentation of twice a year comparison studies for 2023, 2024, and to date of survey 2025 was provided at the time of survey. 3. Interview with the DLS on 1/26/25at 11:40 a.m. confirmed, the laboratory failed to perform comparison studies on IHC stains performed on three of three Ventana Benchmark staining instruments for 2023, 2024, and to date of survey 2025. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 the review of the laboratory's CMS-209 Laboratory Personnel Report, competency assessment documentation, and interview with the DLS, the technical supervisor (TS) failed to perform competency assessment on one of one cytologist (CT) with the required six elements for 2023, 2024 and to date of survey 2025. Findings: 1. Review of the CMS-209 Laboratory Personnel Report found one cytologist as high complexity testing personnel (TP). 2. The surveyor requested competencies for review. The competencies provided for 2023, and 2024 failed to include the following required elements. a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b. Monitoring the recording and reporting of test results. c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f. Assessment of problem solving -- 2 of 3 -- skills. 3. Interview with the DLS 1/16/25 at 10:05 a.m. confirmed the TS failed to perform competency assessment on one of one CT with the required six elements for 2023, 2024. D6151 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463(b)(3)(4) (b)(3) Providing orientation to all testing personnel; and (b)(4) Evaluating and documenting the competency of all testing personnel. This STANDARD is not met as evidenced by: Based on the review of the CMS 209 personnel form, annual competency documentation, and interview with the DSL, the general supervisor (GS) failed to perform the annual competency assessment which included the six required elements for 11of 11 high complexity TP for 2023 and 2024. Findings: 1. Review of the CMS209 personnel form revealed that 11of 11 TP had performed high complexity testing for more than one year in histology and hematology. 2. The surveyor requested competencies of the 11of 11 TP for review. The competencies provided for 2023 and 2024 failed to include the following required elements. a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b. Monitoring the recording and reporting of test results. c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f. Assessment of problem solving skills. 4. Interview with the DLS on 1/16/25 at 10:05 a.m. confirmed, the GS failed to perform the annual competency assessment which included the six required elements for 11of 11 high complexity TP for 2023 and 2024. -- 3 of 3 --

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 review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish a system for the documentation of complaints reported to the laboratory during the years 2019, 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for documentation of complaints made to the laboratory. 2. The Survey Team requested and the laboratory failed to provide documentation of complaints made to the laboratory for 2019, 2020 and to date of the survey in 2021. 3. During an interview with the Survey Team at 10:00 AM on June 23, 2021 Technical Supervisor #2 confirmed these findings. 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) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation, review of the procedure manual, 2017, 2018 proficiency testing (PT), 1 of 1 patient record, and interview with the laboratory director and the general supervisor, the laboratory failed to enroll in an approved proficiency testing program for the cell identification/white blood cell (WBC) differential analyte in the specialty of hematology. Findings: 1. Observation of the laboratory revealed Giemsa Wright stain for staining peripheral smears. 2. Review of the procedure manual showed a policy for "Slide Review and Manual Differential". 3. Review of l of 1 patient record showed results for manual differential. 4. Review of proficiency records from 2017 to date March 1 , 2019, revealed a lack of enrollment for white blood cell identification /WBC differential analyte. 5. Interview with the laboratory director and general supervisor on March 1, 2019 at 12:00 PM, confirmed the laboratory performed 82 cell identification/white blood cell manual differential counts for 2018 and failed to enroll in an approved PT program. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 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 -- Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation and interview, the laboratory failed to provide a safe environment for employees (refer to D3011). D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of 7 of 7 laboratory staff, the pathology processing room and interview with laboratory staff, the laboratory failed to provide a safe environment in which employees are protected from chemical and biological hazards. Findings: 1. Observation of 7 of 7 laboratory staff showed no laboratory personnel wearing formaldehyde monitoring badges. 2. Observation of the pathology processing room showed one Tissue Tek stainer , one Tissue Tek processor, one Tissue Tek SCA coverslip analyzer, and one stainer with a small hood. 3. Observation of the room by the two CLIA surveyors resulted in the CLIA surveyors having to exit the room within 10 minutes due to nausea, headache and dizziness from the strong fumes. 4. Interview with laboratory staff on March 1, 2019 at 9:30 AM confirmed staff has sinus issues , headaches and dry eye symptoms. 5. Interview with the general supervisor on March 1, 2019 revealed testing personnel (A) had the formaldehyde badge sent into StatLab on December 14, 2018 and had a high result of 0.94 ppm.. 6. Interview wit the laboratory director and owners on March 1, 20 19 at 1:30 PM confirmed testing personnel (A) had a high result on the formaldehyde monitoring badge, the 2 CLIA surveyors experienced an immediate reaction to the fumes within the processing room and confirmed the laboratory failed to provide a safe environment in which employees are protected from chemical and bi logical hazards. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on observation, review of the manufacturer's inserts and interview with laboratory staff, the laboratory failed to monitor and document the humidity and temperature of the rooms used to store reagents and process tissue samples. Findings: 1. Observation of 4 of 4 rooms used to store reagents, gross and process tissue samples showed a lack of room temperature and humidity documentation. 2. Review of the manufacturer's product inserts for Cancer Diagnostic dye reagent for marking tissue samples revealed to store the dye at 59-86 degrees Fahrenheit. 3. Review of the microtome cryostat procedure manual revealed the acceptable operating temperature range is 5-40 degrees Celsius with maximum relative humidity of 60 percent. 4. Interview with laboratory staff and the laboratory director on March 1, 2019 at 2:00 PM confirmed the laboratory failed to monitor and document the room temperature and humidity. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of reagent material, review of procedure and interview with the laboratory director, the laboratory failed to use non expired reagents for histopathology. Findings: l. Observation of the tissue grossing room revealed the following expired Cancer Diagnostics reagents: two bottles of black dye with an expiration date of 9/20l8 two bottles of red dye with an expiration date of 5/2018 two bottles of orange dye with an expiration date of 7/2018 one bottle of yellow dye with an expiration date of l/2018 2. Observation of the reagents in the grossing room revealed 2 unopened and one opened bottles of Clotest control type III with an expiration date of 5/21/2017. 3. Observation of the reagents in the processing room revealed the following expired reagents: one bottle of 80 percent alcohol with an expiration date of 1/2017 one bottle of 95 percent alcohol with no open date one bottle of Giemsa stain with an expiration date of 12/2015 one bottle of Giemsa stain with no open date one bottle phosphatebuffer with an expiration date of 6/2015 one bottle Hemacolor solution with an expiration date of 1/2013 4. Review of the procedure for Reagents and Solutions showed "reagents and solutions must be labeled to indicate: identity and strength, preparation and expiration date, recommended storage requirements, NFPA code, and other pertinent information." 5. lnterview with the laboratory director on March 1, 2019 at 2:00 PM confirmed the laboratory failed to use non expired reagents and supplies. D6167 CYTOTECHNOLOGIST RESPONSIBILITIES CFR(s): 493.1485(c) The cytotechnologist is responsible for documenting the number of hours spent examining slides in each 24-hour period. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on review of Pap Smear documentation revealed and interview with the laboratory director on March 1, 2019 at 2:00 PM confirmed 4 of 4 testing personnel failed to document the total number of hours spent examining Pap smear slides, in a 24 hour period. -- 4 of 4 --