Ph Dubois, Clearfield Campus

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, lack of documentation, and interview with Technical Supervisor (TS) #3, the laboratory failed to follow established policy's to assess the competency of 1 of 8 technical consultants (TC) for their supervisory duties performed (493.1413) in 2024 and 2025. Findings Include: 1. On the day of survey, 7/24/2025, at 11:30 am, review of the policy titled "Laboratory Competency Assessment Plan" stated, "In addition to completing and maintaining annual competency as testing personnel, titled Laboratory Supervisors and Director must also complete and maintain annual competency for these duties. Supervisory Competency Review and Observation of: 1. Available for Consultation to Laboratory Staff. 2. Proficiency Testing - enrollment confirmed for current year, ongoing participation and review of proficiency testing results with

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 American Proficiency Institute (API) proficiency testing (PT) records and interview with technical supervisor #4 (TS), the laboratory failed to examine 1 of 6 API PT hematology testing events in the same manner as patient specimens in 2021, 2022, and 2023. Findings include: 1. On the day of survey, 07/11 /2023 at 10:06 am, review of the patient test reports and the API PT records revealed that the laboratory failed to examine the following PT samples for 1 of 6 API PT hematology testing events in the same manner as patient specimens in 2021, 2022, and 2023: -2023 API Heme/Coag 1st Event - Body Fluid Crystals - Semen Analysis - Cell Identification 2. During an interview, 07/11/2023 at 10:30 am, TS #4 stated, "PT samples for cell identification, body fluid, and semen analysis were analyzed by two different testing personnel." 3. The laboratory could not provide documentation stating the tests listed above where included in the laboratory's patient repeat criteria. 4. TS #4 confirmed the findings above on 07/12/2023 around 12:00 pm. D3009 FACILITIES CFR(s): 493.1101(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- 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 the technical supervisor (TS) #2, the laboratory failed to ensure a general supervisor (GS ) who met the state requirement was on the laboratory premises during all hours in which tests were performed from 10 /07/2020 through the day of survey. Findings include 1) The PA regulations (5.23(b) (1) states: "A general supervisor who meets all 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, 07/11/2023 at 8:30 am review of Laboratory Personnel Report (Pennsylvania State) and personnel credentials, revealed GS #3 does not meet the education and experience requirements to supervise testing in the laboratory. 3) During an interview with TS #2, it was discovered the laboratory does not have a qualified supervisor onsite for every hour of patient testing according to chapter 5 section 5.23 of the Pennsylvania State regulations for clinical laboratories. 4) On 07/12/2023 TS#2 confirmed the above findings around 12:00 pm D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with technical supervisor #2 (TS), the laboratory failed to record the room temperature for paraffin block storage to ensure proper preservation from 10/07/2020 to the day of the survey. Findings include: 1. On the day of the survey, 07/12/2023 at 10:30 AM, during the laboratory tour it was observed that the paraffin blocks were not stored in a temperature monitored area. 2. The laboratory could not provide the room temperature records for paraffin blocks stored within two sections of the laboratory hallway from 10/07/2020 to the day of the survey. 3. TS #2 confirmed the finding above on 07/12/2023 around 12:00 PM. 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) 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 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 of review of laboratory's Competency Assessment Plan Procedure, laboratory personnel competency assessment records and interview with the Technical Consultant (TC) #1, the laboratory failed to included the 6 points of CLIA competency assessment in their policy, that assess laboratory testing personnel responsible for Chemistry, Hematology, Immunohematology, Microbiology, Immunology and Histopathology in 2017. Findings include: 1. On the days of survey, 08/22/2018 and 08/23/2018, The laboratory could not provide a written policy for the competency assessment that including reviewing personnel for the 6 points of CLIA personnel competency assessment. 2. Review of personnel Competency assessment records revealed: a. 2 of 2 Histology technologist that perform grossing, competency assessments did not include the CLIA 6 points. b. 15 of 17 Laboratory Testing personnel who perform Chemistry, Hematology, Immunohematology, Microbiology and Immunology competency assessments did not include the CLIA 6 points. c. 8 of 9 Respiratory Therapist performing Blood Gases testing were not assessed for competency in 2017. 3. In 2017: 951,886 specimens were tested by the laboratory. 4. TC #1 confirmed the findings above on 08/22/2018 around 10:00 am. 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 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 -- 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 observation of microbiology media, review of temperature records and interview with the Microbiology Supervisor, the laboratory failed to define criteria conditions that are essential for proper storage of reagents, monitored and documented room temperature for various reagents stored in the microbiology laboratory form 2017 to the date of survey. Findings Include: 1. On the day of survey, 08/23/2018, review of temperature records revealed the microbiology laboratory was not recording and documenting daily room temperature. 2. Observation of a sample of reagents and media boxes found around the microbiology laboratory revealed: 3 of 3 boxes of tube media stated on the box to be stored between 2-25 degrees Celsius. 6 of 6 bottles of identification regent stated on the bottle to be stored between the temperatures of 15- 30 degrees Celsius. 3. The MS confirmed the findings above on 08/23/2018 around 10: 45 am. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory Tour, observation of Tissue Marking Dye bottles and interview with the Technical Consultant (TC) #1, the laboratory failed to label 8 of 8 stock and aliquot bottles of TBS Tissue Marking Dye and 1 of 1 bottle set of Davidson Tissue Marking Dye with an open and expiration dates from 2017 to the date of survey. Findings Include: 1. On the day of survey, 08/22/2018 to 08/23/2018, a tour of the Tissue pathology laboratory revealed that the laboratory did not write the open and expiration date on TBS Tissue Marking Dye stock and aliquot bottles (8 of 8 bottles) in use and on the Davidson Tissue Marking Dye set (5 of 5 bottles). 2. The TC#1 confirmed the findings above on 08/22/2018 around 11:30 am. 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 tour of Laboratory and interview with the Technical Consultant (TC) #1, the laboratory failed to ensure that 1 of 1 bottle of Cancer Diagnostics Inc. (CDI) Tissue -- 2 of 3 -- Marking Dye was not used beyond expiration date. Finding Include: 1. On the days of the survey, 08/22/2018 and 08/23/2018, during the tour of the laboratory, 1 of 1 bottle of Orange Cancer Diagnostics Inc. (CDI) Tissue Marking Dye was found that expired 12/2017. 2. The TC confirmed the above finding on 08/22/2018 around 11:45 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 chemistry calibration records, interview with the Technical Consultant (TC)#1, General Supervisor (GS) #2 and Testing personnel (TP) #9, the laboratory failed to have a system in place, that twice a year evaluates and defines the relationship between two Chemistry Siemens Dimension Vista 500's in 2017. Findings Include: 1. On the days of survey, 08/22/2018 and 08/23/2018, review in instrument calibration records reveals that the laboratory failed to perform relationship studies at least twice a year on 2 of 2 Siemens Dimension Vista 500's. 2. In 2017: 667,859 chemistry tests were performed. 3. The TC and GS confirmed thin findings above on 08/23/2018 around 9:45 am. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of specimen test requisitions and interviews it was determined that the laboratory failed to ensure that four of four nongynecologic test requisitions from November through December 2017 solicited the sex of the patient. Findings include: 1. The Survey Team reviewed specimen test requisitions used for submitting nongynecologic outpatient specimens. The test requisitions failed to solicit the sex of the patient. Requisitions include: 03-NG-17-0000545 03-NG-17-0000548 03-NG-17- 0000560 03-NG-17-0000579 2. During an interview on 1/29/18 at 11:45 AM, STAFF A stated that the requisitions were used by outpatient offices and confirmed that the test requisitions did not solicit the sex of the patient. 3. During an interview on 1/30 /18 at 3:00 PM, the Laboratory Director/Technical Supervisor A confirmed these 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 3 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of thirty-four laboratory policies and procedures, observation and interviews it was determined that the laboratory failed to follow one written policy and procedure. Cross refer to D5821 Findings include: 1. The laboratory failed to follow the written procedure titled FINAL, ADDENDUM, AND CORRECTED CYTOLOGY REPORT FORMAT POLICY (signed and dated by the Laboratory Director on 12/20/17) which stated: "A copy of the original final report and corrected or addendum report are retained in the legal health record. The new report is automatically sent to the ordering physician by Cerner." D5631 CYTOLOGY CFR(s): 493.1274(c)(6) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (6) An evaluation of the case reviews of each individual examining slides against the laboratory's overall statistical values, documentation of any discrepancies, including reasons for the deviation, and, if appropriate,