Penn Highlands Tyrone

Summary Statement of Deficiencies 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 laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and interview with Technical Supervisor #1 (CMS 209 #1) the laboratory failed to verify the accuracy of the PT results obtained for 2 of 3 API PT testing events reviewed in 2023. Findings include: 1. The API PT Performance Evaluation stated the following, "Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or 'not graded' analytes. Laboratories are responsible for documenting and performing

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 review of the CASPER 155 report and graded results from the proficiency testing (PT) organization, American Proficiency Institute (API), the laboratory failed to successfully participate in PT for Compatiblity Testing in the specialty of Immunohematology. The laboratory had unsatisfactory scores for the 2nd event of 2023 and the 1st event of 2024. Refer to D2181 and 2173. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) 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 -- 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 American Proficiency Institute (API) proficiency testing (PT) organization, the laboratory failed to attain an overall testing event score of atleast 100 percent for Compatibility Testing in the specialty of Immunohematology. The laboratory had unsatisfactory scores for the 2nd event of 2023 and the 1st event of 2024. Findings include: Analyte Year Event Score PT Agency Compatibility 2023 2 80% API Compatibility 2024 1 80% API D2181 COMPATIBILITY TESTING CFR(s): 493.863(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 155 report and graded results from the American Proficiency Institute (API) proficiency testing (PT) organization, the laboratory failed to successfully participate in PT for Compatibility Testing in the specialty of Immunohematology for two out of three consecutive testing events. The laboratory had unsatisfactory scores for the 2nd event of 2023 and the 1st event of 2024. Findings include: Analyte Year Event Score PT Agency Compatibility 2023 2 80% API Compatibility 2024 1 80% API -- 2 of 2 --

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 the lack of documentation and an interview with General Supervisor (GS) #1, the laboratory failed to verify twice annually the accuracy of nicotine examinations performed from 11/11/21 through the date of the survey. Findings include: 1. On the day of the survey, 12/07/2022 at 12:09 pm, the laboratory could not provide documentation of verification of accuracy for nicotine examinations performed from 11/11/2021 to 12/08/2022. 2. GS #1 confirmed the findings above on 12/08/2022 around 03:00 pm. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with General Supervisor (GS) #1, the laboratory failed to document the evaluation and verification activities for PT testing performed in microbiology, chemistry, hematology/coagulation, and immunology /immunohematology from 09/17/2020 to the date of the survey. Findings Include: 1. On the day of the survey, 12/07/2022 at 08:25 am, a review of API proficiency testing records revealed that the laboratory did not document the review and

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 competency assessment records and interview with Technical Supervisor (TC), the laboratory failed to establish written policies and procedures to assess competency for 1 of 1 Technical Consultant, 1 of 2 Technical Supervisors, and 4 of 5 General Supervisors from (07/18/2018) through the date of the survey (09/16 /2020). Findings include: 1. At the time of the survey, the laboratory could not provide written policies and procedures to assess Technical Consultant, Technical Supervisor, & General Supervisor competency. 2. A review of the competency assessment records revealed there was no documentation of supervisor competency assessment from (07/18/2018) through the date of the survey (09/16/2020). 3. During the survey at (10:30 09/16/2020), the Technical Supervisor confirmed, the above findings. 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 Technical Consultant on the date of the survey (06/16/2020), the Laboratory failed to ensure 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 -- review and evaluation of the results obtained on proficiency testing for 2 of 10 American Proficiency Institute (API) 2019 2nd event analytes. Findings include: 1. A review of API proficiency test records revealed a score of 80%, of 1 of 5 for Fibrinogen (COA-06) 2019 2ND event and a score of 80%, of 1 of 5 for Eosinophils (Hem-5C2) 2019 2ND event. 2. The laboratory could not provide documentation of evaluation & review performed on the 2019 API Fibrinogen and Eosinophil 2nd event. 3. During the survey (10:30 06/16/2020), the Technical Supervisor confirmed the above findings. -- 2 of 2 --

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 on (07/18/2018), the laboratory failed to include a positive and negative control each day of patient testing for KOH, Wet Prep, and Urine Sediment examination, from January 2017 through the date of the survey (07/18/2018). Findings include: 1.The labororatory did not document a negative and positive control material at least once a day patients specimens were examined for KOH, Wet Prep, and Urine Sediment Examination for 18 of 18 months on tests preformed from January 2017 through the date of survey (07/18/2018). 2. During the survey, the Laboratory Manager, confirmed that positive and negative controls are not documented each day of patient testing for KOH, Wet Prep, and Urine Sediment Examination. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 performance evaluations from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Compatibility Testing which is in the specialty of Immunohematology. The laboratory had unsatisfactory scores for the 2nd event of 2017 and the 1st event of 2018. See D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- 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 155 report and performance evaluations from the proficiency testing organization American Proficiency Institute (API),the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Compatibility Testing which is in the specialty of Immunohematology in which the laboratory is certified under CLIA. The laboratory had unsatisfactory scores for the 2nd event of 2017 and the 1st event of 2018. Findings include: 1. API 2017 Event 2 for Compatibility Testing the score was 80% and was unsatisfactory. 2. API 2018 Event 1 for Compatibility Testing the score was 80% and was unsatisfactory. -- 2 of 2 --