Bucktail Medical Center

Summary Statement of Deficiencies D0000 A desk review for proficiency testing results was conducted by the Pennsylvania State Agency for Bucktail Medical Center on 08/13/2025. The laboratory was found out of compliance with the following conditions: 493.803 Condition: Successful participation. 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 review of the CASPER 0155 report and graded results from the proficiency testing (PT) organization, Wisconsin State Laboratory of Hygiene (WSLH), the 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 -- laboratory failed to successfully participate in PT for Unexpected Antibody Identification (ABID). The laboratory had unsatisfactory scores for the 1st and 2nd Events of 2025. Refer to D2164 and D2172. D2164 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(a) (a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 155 report and graded results from the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) organization, the laboratory failed to attain an overall testing event score of at least 100 percent for 2 of 2 WSLH PT events in 2025 for Unexpected Antibody Identification (ABID) in the specialty of Immunohematology. The laboratory had unsatisfactory scores for the 1st and 2nd events of 2025. Findings Include: 1. Review of the CASPER 0155 report revealed the following unsatisfactory scores: - 2025 Event 1 ABID: 0% - 2025 Event 2 ABID: 80% 2. Further review of the laboratory's 2025 WSLH PT agency's graded results confirmed the above findings of failure to attain an overall testing score of at least 100 percent for 2 of 2 WSLH Events in 2025 ABID testing (Immunohematology). D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER 0155 Report and graded results from the proficiency testing (PT) organization, Wisconsin State Laboratory of Hygiene (WSLH), the laboratory failed to achieve an overall testing score of satisfactory performance for 2 of 2 WSLH PT events in 2025 for Unexpected Antibody Identification (ABID) testing (Immunohematology). The laboratory had unsatisfactory scores for the 1st and 2nd events of 2025. Findings include: 1. Review of the CASPER 0155 report revealed the following unsatisfactory scores: - 2025 Event 1 ABID: 0% - 2025 Event 2 ABID: 80% 2. Further review of the laboratory's 2025 WSLH PT agency's graded results confirmed the above findings resulting in unsuccessful performance for ABID testing (Immunohematology) for 2 of 2 WSLH Events in 2025. -- 2 of 2 --

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without 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 review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to verify the accuracy of analytes that were not evaluated or scored for 2 of 3 WSLH hematology/coagulation PT events in 2023. Findings include: 1. On the day of survey, 10/24/2023 at 12:15 PM, review of the laboratory's WSLH PT records revealed that the laboratory did not verify the accuracy for the following WSLH PT events that were not graded due to non consensus in 2021,2022, and 2023: WSLH PT 2023 HemeReg1- Toxic Granulation- Basophil WSLH PT 2023 SpecialChemistry2-Tumor Markers Prostate Specific Antigen (PSA) WSLH PT 2023 Chem/Endo/TX1- Chemistry CO2 WSLH PT 2022 SpecialChemistry2- Tumor Markers Prostate Specific Antigen (PSA) WSLH PT 2022 BloodGas1- Chemistry Urea Nitrogen (BUN) WSLH PT 2022 BloodGas2- Chemistry Urea Nitrogen (BUN) WSLH PT 2022 Chem/Endo/Tx1- Chemistry Alanine Aminotransferase (ALT) WSLH PT 2021 Chem/Endo/Tx3- Chemistry Cholesterol WSLH PT 2021 Chem/Endo /Tx3- Chemistry Lipase WSLH PT 2021 HemeReg3-Hematology RDW WSLH PT 2021 BloodGas3- Chemistry Urea Nitrogen (BUN) 2. The TS confirmed the findings above on 10/24/2023 at 04:00 PM. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or 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 -- 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 the Technical Supervisor (TS), the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results using different methodologies and instrumentation for examinations performed in hematology from 10/13/2021 to the date of the survey. Findings include: 1. On the day of the survey, 10/24/2023, the laboratory failed to provide documentation of the biannual comparison of test results for the following tests performed in hematology from 10/13/2021 to 10/24/2023: -White blood cell differentials: manual microscopic vs. automated (Sysmex XNL 430) 2. The laboratory performed 14,460 hematology tests in 2022 (CMS 116 annual volume). 3. The TS confirmed the findings above on 10/23/2023 at 04:10 PM. 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 competency assessment records and interview with the Technical Supervisor (TS), the TS failed to assess the competency of 13 of 16 testing personnel (TP) that performed Clinical Chemistry, Virology and Urinalysis testing in 2022. Findings include: 1. On the day of the survey, 10/26/2023, at 10:11 AM, review of the laboratory's competency assessment records and patient test reports revealed that the TS did not assess the competency of 13 of the TP (CMS 209 TP #2, 3,4,5,6,7,8,9,10,11,12,13,14) that performed Clinical Chemistry, Virology and Urinalysis testing in 2022. 2. The TS confirmed the findings above on 10/26/2023 at 04:00 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 review of the laboratory's Individualized Quality Control Plan (IQCP) records and interview with the Technical Supervisor (TS), the Laboratory Director (LD) failed to maintain a quality assessment program to assure the quality of laboratory services provided in microbiology and coagulation testing performed in 2022 and 2023. Findings Included: 1. On the day of survey, 10/24/2023 at 3:30 PM, a review of laboratory's IQCP record revealed that the LD failed to review the IQCP for the following tests performed in 2022 and 2023. - D Dimer. - Clostridium difficile (C -- 2 of 3 -- diff). 2. According to the laboratory's IQCP procedure, the LD should review the IQCP procedure yearly. 3. The TS confirmed the findings above on 10/24/2023 at 4: 00 PM. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and interview with the Technical Supervisor (TS)#2, the Laboratory Director (LD) failed to sign the AAB and WSLH PT attestation statement documents for 2019, 2020, and 2021. Findings include: 1. On the day of survey, 10/13/2021, review of AAB and WSLH PT records revealed, that 9 of 9 immunohematology attestation statements were not signed by the LD for 2019, 2020, and 2021. 2. The laboraotry could not provide attestation statement for WSLH Chemistry event 2 in 2020. 3. The TS#2 confirmed the findings above on 10/13/2021 at 11:25 a.m. 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: A. Based on review of the laboratory's Employee Competency procedure and interview with Testing Personnel (TP) #2, the laboratory failed to have a complete policy to assess the competency of 1 of 2 Technical Supervisor (TS) and 1 of 1 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 -- General Supervisor (GS) for their supervisory roles from 10/13/2019 to the date of survey. Findings include: 1. On the day of survey, 10/13/2021, the TP#2 could not provide a competency assessment policy to assess the competency of the following personnel from 10/13/2019 to the date of survey: - 1 of 2 TS (on CMS 209, listed as personnel #2). - 1 of 1 GS (on CMS 209, listed as personnel #2). 2. The TP#2 confirmed the finding above on 10/13/2021 around 10:15 a.m. B. Based on lack of annual competency records, review of the laboratory's Employee Competency procedure,and interview with Testing Personnel (TP) #2, the laboratory failed to follow their procedure for competency assessment for all TP who performed patient testing in Hematology, Chemistry, Microbiology, and Blood Bank for 2019 and 2020 Findings include: 1. The laboratory procedure manual titled "Employee Competency Assessment" states: - "Competency of testing personnel at the Bucktail Medical center laboratory is assessed on a yearly basis". - "The laboratory competency Form will be used for each technologist working at Bucktail Medical Center clinical laboratory and staff trained to performed testing in the Emergency Department". 2. On the day of survey 10/13/2021, TP#2 could not provided the following competency assessment for the testing personnel: - 2019 : 1 of 2 TP (CMS 209 personnel #3) responsible for testing in hematology, chemistry, microbiology and blood bank. 8 of 8 TP (CMS 209 personnel #4, 5, 6, 7, 8, 9, 10, and 11) responsible for testing at the emergency department ( EPOC, Istat, and Sysmex POCH 100I). - 2020: 1 of 2 TP (CMS 209 Personnel #3) missing competency assessment documentation for hematology, Istat, and Sysmex POCH 100I. 8 of 8 TP (CMS 209 personnel #4, 5, 6, 7, 8, 9, 10, and 11) responsible for testing at the emergency department ( EPOC, Istat, and Sysmex POCH 100I). 3. The TP#2 confirmed the findings above on 10/13/2021 at 10:15 a.m. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of quality assessment (QA) documents and interview with the testing personnel (TP)#2, the laboratory failed to establish a quality assurance policy from 10 /13/2019 to the date of survey. Findings Include: 1. On the day of survey, 10/13/2021, the laboratory could not provide a policy for monitoring its pre-analytical, analytical, and post analytic programs form 10/13/2019 to the date of survey. 2. The TP#2 confirmed the finding above on 10/13/2021 around 11:55 a.m. 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) -- 2 of 5 -- 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 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 graded results from the proficiency testing organization Wisconsin State Lab of Hygiene (WSLH) and American Association of Bioanalysts, the laboratory failed to successfully participate in proficiency testing for the analyte Prothrombin Time. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 155 report and graded results from the proficiency testing organization Wisconsin State Lab Hygiene (WSLH) and American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte: Prothrombin Time (PT). The laboratory had unsatisfactory scores for the 3rd event of 2019, and 1st event 2020. Findings include: Analyte Year Event Score PT Program PT 2019 3 0 AAB PT 2020 1 60 WSLH -- 2 of 2 --

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 the labortaory manager (LM), the laboratory failed to establish a complete competency assessment procedure to assess the competency of testing personnel (TP) who performed chemistry, hematology, immunohematology, and urinalysis tests and technical consultants in 2018. Findings Include: 1. On the day of survey, 06/11/2019, review of personnel records revealed, the laboratory failed to provide a complete written policy on how to assess the competency of testing personnel (TP) who performed chemistry, hematology, immunohematology, and urinalysis tests and clinical consultant competency in 2018. 2. The laboratory could not provide competency assessment records from in 2018 for: - 1 of 2 TP who performed chemistry, hematology, immunohematology, and urinalysis tests. - 9 to 8 TP who performed chemistry tests (Troponin, Lactic acid and Blood Gases). - 1 of 1 technical consultant. 3. In 2018 (01 /01/2018 to 12/31/2019), 41,388 patient tests were analyzed. 4. The LM confirmed the findings above on 06/11/2019 around 09:30 am. 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. 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 review of procedure manuals and interview with the laboratory Manager (LM), the labortaory failed to have a written procedure manual (1 of 1) available to testing personnel (TP) for the coagulation tests performed on the Sysmex CA 660. Findings Include: 1. On the day of survey, 06/11/2019, the laboratory could not provide 1 of 1 procedure manual for coagulation tests performed on the Sysmex CA 660. 2. The LM confirmed the findings above on 06/11/2019 around 12:15 am. 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 interview with the laboratory Manager (LM) and a review of calibration verification (Cal Ver.) records at the time of inspection, the laboratory failed to perform calibration verification on the Chemistry AU480 analyzer and TOSOH AIA 360 once every 6 months for 7 of 7 analytes Cal. Ver. record's reviewed from 9/21/17 through the date of survey 6/11/2019. Findings include: 1. From 2017 to the date of survey, the following Chemistry tests were performed on the AU480 analyzer - Creatine, ALP (Alkaline Phosphatase), HDL (high-density lipoprotein) CO2 (Carbondioxide), Fe (Iron), ETOH (Ethyl alcohol). While the PSA (Prostate-specific antigen) test was performed on the TOSOH AIA 360. 2. Records reviewed at the time of inspection revealed the following Calibration Verification dates: Routine Chemistry Creatinine - 1/29/18, 5/10/19 (once a year) ALP - 1/29/18 (once a year) HDL - 9/21/17, 5/10/19 (No Cal Ver. performed in 2018) CO2, Fe, ETOH - 1/24/18, 1 /21/19 (once a year) Endocrinology PSA - 11/28/18 (once a year) 3. Patient testing performed from 2017 to 6/14/2019: YEAR 2017 2018 2019 Creatinine 2208 2195 1006 ALP 1697 1657 827 HDL 1187 1217 597 YEAR 2017 2018 2019 CO2 2136 2121 983 Fe 105 105 41 ETOH 33 13 8 4. The LM interviewed on 6/13/19 around 09: 40 am during the inspection confirmed the above findings. -- 2 of 3 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Abbott i - stat quality control (QC) logs and interview with laboratory manager (LM), the laboratory failed to perform control procedures as required for the Troponin, Lactic acid, and Blood gases tests performed on the Abbott i- stat analyzer at least once each day of testing from 7/7/2017 through the date of survey. About 2 of 2 years records reviewed Findings include: 1. The following tests were performed on the I- Stat analyzer with the catridges listed: Troponin - cTnl Lactic acid - CG4+ Blood Gases - CG4+ 2. Records reviewed at the time of survey revealed, the laboratory performed external QC monthly for the Troponin, and Lactic acid tests from 7/7/17 through the date of survey. The laboratory did not have an Individualized Quality Control Plan (IQCP). 3. Blood gas analysis was performed on 1of 1 patient specimen on May 1, 2019 with no external QC. Troponin tests (476 patients) and Lactic acid tests (202 patients) performed in 2018 and 2019 with external QC performed monthly. 4. The LM confirmed the findings above at 9:35 am on 6/11/19. 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 review of urine sediment microscopic examination records, and interview with the laboratory manager (LM), the laboratory failed to document QC procedures performed for 1044 of 1044 patient specimens examined for urine sediment microscopic procedure from 2017 to the date of survey. Findings Include: 1. On the day of survey, 06/11/2019, review of urine sediment microscopic examination records revealed the laboratory did not document QC procedures performed each day of patient testing from 08/02/2017 to 06/11/2019. 2. In 2017 (08/02/2017 to 12/31/2017), 255 Urine Sediment Microscopic Examination were analyzed. 3. In 2018 (01/01/2018 to 12/31/2018), 558 Urine Sediment Microscopic Examination were analyzed. 4. In 2019 (01/01/2019 to 06/11/2019), 231 Urine Sediment Microscopic Examination were analyzed. 5. The LM confirmed on 06/11/2019 around 10:45 am. -- 3 of 3 --