Titusville Area Hospital

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of personnel records, thePennsylvania State Laboratory Personnel Report (PA LPR) and interview with the laboratory director and technical supervisor (TS) #2 , the laboratory director/owner failed to ensure that 1 of 7 ( PA LPR GS #5) supervisors met the qualifications specified in the Pennsylvania (PA) Clinical Lab Act from 09/15/2022 to the date of the survey. Findings include: 1. The PA regulations (5.23(a)(3) states: "He shall hold a B.S or A.B degree from an accredited institution with a major in medical technology or one of the biological, physical or chemical sciences and shall have had at least 6 years experiences acceptable to the department in one or more of the applicable categories in the clinical laboratory." 2. A review of personnel credentials offsite revealed that 1 of 7 supervisors (PA LPR GS #5) has a associate degree in specialized technology (major in medical laboratory technician). 3. The LD and TC #2 confirmed the findings above on 03/10/2024 at 3:30 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 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 -- 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 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 the histopathology department and interview with the Histotechnologist, the laboratory failed to establish and follow safety procedures to keep 3 of 3 containers of Xylene in the correct storage area on the date of survey. Findings: 1. Epredia Xylene Safety Data Sheets (SDS) states for storage of xylene reagent, " Keep containers tightly closed in a dry, cool and well-ventilated place. Keep away from heat, sparks, flame and other sources of ignition (i.e., pilot lights, electric motors and static electricity). Keep in properly labeled containers. Do not store near combustible materials. Keep in an area equipped with sprinklers. Store in accordance with the particular national regulations. Store in accordance with local regulations. Store locked up. Keep out of the reach of children. Store away from other materials." 2. The surveyor observed on 9/14/2022 at 09:25, 3 of 3 bottles of Xylene were in a cabinet with other laboratory reagents in the Histopathology area, the cabinet was not appropriate for storage of flammable reagents. 3. Interview with the HT, on 09/14/2022 at 09:30 am, confirmed the above findings. 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. 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 -- This STANDARD is not met as evidenced by: A. Based on review of the laboratory's competency policy, competency assessment records and interview with the Laboratory Manager (LM), the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 2 Technical Consultants (TC), 1 of 2 Technical Supervisors (TS), and 1 of 12 General Supervisors (GS) for their supervisory roles from 06/17/2020 to the date of survey. Findings include: 1. On the day of survey, 09/14/2022 at 09:33 am, the LM could not provide a competency assessment policy to assess the competency of the following personnel for their supervisory skills from 06/17/2020 to 09/14/2022: - 1 of 2 TC (on CMS 209, personnel #2) - 1 of 2 TS (on CMS 209, personnel #2) - 1 of 12 GS (on CMS 209, personnel #2) 2. The LM could not provide documentation for delegation of duties for the TS,TC,GS (CMS 209, personnel #2). 3. The LM confirmed the findings above on 09/15/2022 around 02:15 pm. B. Based on review of the laboratory's Employee Competency procedure, annual competency records, and interview with Laboratory Manager (LM), the laboratory failed to establish a complete procedure that includes all six components required for competency assessment for 13 of 13 Testing Personnel who performed Hematology, Routine Chemistry, Urinalysis, Microbiology and Immunohematology examinations from 06 /17/2020 to the date of survey. Findings include: 1. On the day of survey, 09/14/2022 at 10:40 am, the competency assessment policy reviewed at the time of survey did not include the six points of CLIA required for competency assessment. 2. The LM confirmed the findings above on 09/15/2020 around 02:15 p.m. *This is a repeat deficiency. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the laboratory manager (LM), the laboratory failed to verify the accuracy for PT testing performed in 2020, 2021, and 2022. Findings Include: 1. On the day of survey, 09/14/2022 at 10:30 am, review of the laboratorys API proficiency testing records revealed that the laboratory did not verify the accuracy for the following analytes that were not graded by the proficiency testing agency: a.) 2022 Microbiolgy 2nd Event: -12 of 12 Blood Culture MIC/Zone Diameter Value -12 of 12 Blood Culture Susceptibility Interpretation -12 of 12 Urine Culture MIC/Zone Diamether Value b.) 2022 Immunology/Immunohematology 1st Event: -1 of 5 Antigen Identification (Blood Bank Compatibility) -1 of 5 Ortho ID- MTS Anti-IgG Gel Test c.) 2022 Microbiology 1st Event: -9 of 9 CSF Culture MIC /Zone Diameter Value -9 of 9 CSF Culture Susceptibility Interpretation -1 of 5 Gram Stain -8 of 8 Urine Culture MIC/Zone Diameter Value d.) 2021 Hematology /Coagulation 2nd Event: -1 of 5 Blood Cell Identification -1 of 2 Sperm Count (Hemacytometer) e.) 2021 Immunology/Immunohematology 3rd Event -1 of 5 Antigen Identification (Blood Bank Compatibility) f.) 2021 Chemistry Event #2: -1 of 2 Folate g.) 2021 Chemistry-Miscellaneous 1st Event -1 of 3 Body Fluid Creatinine -- 2 of 5 -- h.) 2020 Microbiology 3rd Event: -1 of 2 Wound Culture (non consensus) i.) 2020 SARS-CoV2 3rd Event: -1 of 2 SARS-CoV2 Liquid (Molecular) 2. The LM confirmed the findings above on 09/15/2022 around 02:15 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 on review of the laboratory's procedure manuals and interview with technical supervisor (TS), the laboratory failed to follow their competency assessment policy to evaluate the competency of 11 of 12 testing personnel (TP) and to establish a policy to access the competency of 9 of 10 regulatory personnel in 2019 and 2020. Findings include: 1. The Laboratory Employee Competency policy states "Competency assessment, which includes six procedures must be performed for testing personnel for each test that the individual is approved by the laboratory director to performed. Evaluating and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual tests patients specimen. Thereafter, competency assessment must be performed at least annually". 2. On the day of survey, 06/17/2020, the laboratory did not assess the competency of 11 of 12 TP for each test they were approved by the laboratory director to performed in 2019 and 2020 and did not evaluate the competency of 2 of 2 new TP for semiannual competency in 2020. 3. The laboratory employee competency policy did not include measures to assess the competency of 9 out of 10 regulatory personnel in 2019 and 2020. 4. The TS confirmed the findings above on 06/17/2020 around 10:00 am. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without 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 -- analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on laboratory record review, and interview with the technical supervisor (TS), the laboratory director failed perform and verify the accuracy of Lactophenol cotton blue smear examinations performed from 06/20/2018 to the day of survey. Findings include: 1. On the day of survey, 06/17/2020, The TS could not provided documentation of proficiency testing performed or documentation of accuracy performed for Lactophenol cotton blue smear examinations performed in 2018, 2019 and 2020. 2. The TS confirmed the finding above on 06/17/2020 around 2:15 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 D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Laboratory Quality Control record review and interview with the Laboratory Manager, the laboratory failed to document a positive and negative control each day patients specimens were examined for microscopic elements for 17 of 17 months. Findings include: 1. The laboratory failed to document Quality Control for 13 of 13 specimens tested for sperm morphology between 01/01/2017 and 06/20/2018. 2. The laboratory failed to document Quality Control for 145 of 145 wet prep specimens tested between 01/02/2017 and 06/13/2018. from January 2017 through the date of the survey, 12/20/2017. 3. The laboratory failed to document Quality Control for all Urine Sediment Examinations, performed from 01/01/2017 through 06/20/2018. 4. During the survey, the Laboratory Manager, confirmed the above findings. . D5517 MYCOLOGY CFR(s): 493.1263(a)(c) The laboratory must check each batch (prepared in-house), lot number (commercially prepared), and shipment of lactophenol cotton blue when prepared or opened for intended reactivity with a control organism(s). (c) The laboratory must document all control procedures performed, as specified in this section. 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 -- This STANDARD is not met as evidenced by: By review of microbiology quality control records and interview of Technical Supervisor 2 , at the time of survey (09:30 06/20/2018), the laboratory failed to document control procedures for each shipment of lactophenol cotton blue when opened, for 9 of 9 specimens tested between 02/21/2017 and 06/13/2018. Findings include: 1.. On the date of the survey (06/20/2018), there was no documentation of lactophenol cotton blue intended reactivity, for 9 of 9 specimens tested between 02/21 /2017 and 06/13/2018. 2. During the survey Technical Supervisor 2 confirmed the above finding. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: By review of personnel records and interview of Technical Supervisor 2 , at the time of survey (09:30 06/20/2018), the Technical Supervisor did not document the performance of 11 of 13 high complexity testing personnel annually, Findings include: 1.. On the date of the survey (06/20/2018), there was no documentation of competency assessment for 11 of 13 high complexity testing personnel in 2017. 2. During the survey Technical Supervisor 2 confirmed the above finding. -- 2 of 2 --