Penn Highlands Dubois

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted by the Pennsylvania State Agency for Penn Highlands Dubois on 10/21/2025 and 10/22/2025. The laboratory was found out of compliance with the following conditions: 493.1250 Condition: Analytic Systems 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor. 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 record review, lack of documentation, and interview with Technical Supervisor (TS) #3, the laboratory failed to monitor and document temperature and humidity to ensure reagent storage requirements were met as per PA regulations when 1 of 1 chemistry test (Whole Blood Glucose) was performed from 11/16/2023 to 10/22 /2025. Findings include: 1. On the day of the survey, 10/22/2025 at 1:00 pm, review of the laboratory's Accu-Chek Inform Blood Glucose Determination policy stated, " Store the strips at room temperature at 59 to 86 degrees Fahrenheit (15 to 30 degrees Celsius)." 2. The laboratory failed to provide documentation for the monitoring of temperatures to ensure reagent storage requirements for the Accu-Chek Inform Blood Glucose strips were met for 1 of 1 chemistry test (Whole Blood Glucose) performed in the point of care areas from 11/16/2023 to 10/22/2025. 3. TS #3 confirmed the findings above on 10/22/2025 at 2:00 pm. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with Technical Supervisor (TS) #3, the laboratory failed to retain weekly microbiology susceptibility quality control (QC) records for 23 of 24 months as required from 11/16/2023 to 10/21 /2025. Findings include: 1. On the day of survey, 10/21/2025 at 11:30 am, review of laboratory microbiology weekly QC records and interview with TS #3 revealed that only cumulative microbiology chart reports for susceptibility QC are retained by the laboratory. 2. The laboratory failed to provide the individual microbiology chart reports for QC organism testing performed for 23 of 24 months from 11/16/2023 to 10 /21/2025. 3. TS#3 confirmed the findings above on 10/22/2025 at 1:15 pm. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) (a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with General Supervisor (GS) #1 , the laboratory failed to retain chemistry quality system assessment records for 23 of 24 months as required from 11/16/2023 to 10/21/2025. Findings include: 1. On the day of survey, 10/21/2025 at 12:30 pm, review of laboratory policy titled Daily Surveillance of Results stated, "Daily Exception and Correction reports are reviewed by Supervisor or delegate". 2. The laboratory failed to provide documentation of the exception and correction reports reviewed by the supervisor or delegate for 23 of 24 months from 11/16/2023 to 10/21/2025. 3. GS #1 confirmed the findings above, on 10/21/2025 at 1:15 pm, and stated "the exception /correction reports are only kept for 30 days". D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, and interview with General Supervisor (GS) #3, the laboratory failed to meet applicable analytic systems requirements in 493.1251 through 493.1283 from 11/16/2023 to date of survey. Refer to D5413, D5415, D5417, D5423, D5429, D5439, D5445, D5601, D5775, and D5783. -- 2 of 14 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: A. Based on lack of documentation and interview with Technical Supervisor (TS) #3, the laboratory failed to monitor the humidity of the laboratory to ensure proper operating conditions were met for 8 of 8 laboratory areas where microbiology, hematology (urinalysis), histopathology, cytology, chemistry (blood gas), coagulation, immunology, and immunohematology testing was performed from 11/16/2023 to 10/1 /2025. Findings include: 1. On the day of survey, 10/21/2025, at 10:00 am, the laboratory failed to provide documentation of humidity monitoring for 8 of 8 laboratory areas to ensure operating conditions were met where microbiology, hematology (urinalysis), histopathology, cytology, chemistry (blood gas), coagulation, immunology, and immunohematology testing was performed from 11/16/2023 to 10/1 /2025. 2. The laboratory performed 2,058,783 total tests/examinations in 2024 (CMS 116,estimated annual volume, dated 10/1/2025). 3. TS #3 confirmed the findings above on 10/21/2025 at 12:30 pm. B. Based on observation in the laboratory, review of laboratory temperature records, and interview with General Supervisor (GS) #5, the laboratory failed to monitor room temperatures to ensure acceptable reagent storage temperatures were maintained on weekends and holidays for 481 of 708 days from 11 /16/2023 to 10/22/2025. Findings include: 1. On the day of survey, 10/22/2025, at 11: 30 am, during the tour of the laboratory, the surveyor observed the following reagents stored in the laboratory: - Dako Artisan Wash Solution. Storage requirements 15C to 30C. - Cardinal Health Formalin. Storage requirements 15C to 30C. 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document room temperatures to ensure acceptable reagent storage temperatures were maintained for 481 of 708 days from 11/16/2023 to 10/22/2025 when the laboratory was closed. 3. GS #5 confirmed the findings above on 10/22/2025 at 11:45 am. C. Based on observation in the laboratory, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to monitor daily temperatures and humidity to ensure proper operating conditions were met for 3 of 3 Olympus microscopes used to perform microscopic histopathology and cytology examinations from 11/16/2023 to 10/22/2025. 1. Review of the manufacturer's instructions revealed the following acceptable operating temperature and humidity range for the Olympus BX 53, BX45, and DP72 microscopes: - Temperature 5C to 40C - Humidity 0 to 80% Relative Humidity 2. On the day of the survey, 10/22/2025 at 11:15 am, the laboratory failed to provide temperature and relative humidity documentation to ensure proper operating conditions were met for 3 of 3 Olympus microscopes used to perform microscopic histopathology and cytology examinations from 11/16/2023 to 10/22 /2025. 3. The LD confirmed the findings above on 10/22/2025 at 11:30 am. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) -- 3 of 14 -- (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations of the laboratory and interview with General Supervisors (GS) #3 and #5, the laboratory failed to label 4 of 4 aliquoted reagents with the pertinent information required for proper use when manual stain examinations were performed from 11/16/2023 to 10/21/2025. Findings Include: 1. On the day of survey, 10/22 /2025 at 11:30 am, during the laboratory tour, observation of the hematology and histology departments revealed 4 of 4 containers used to aliquot manual staining reagents were not properly labeled with the following when manual stain examinations were performed from 11/16/2023 to 10/21/2025: - Identity of reagent - Storage requirements - Preparation and expiration dates 2. GS#3 and GS#5 confirmed the findings above on 10/22/2025 at 3:46 pm. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 the laboratory and interview with the General Supervisor (GS) #3, the laboratory failed to ensure that 2 of 3 reagents used to prepare microscopic hematology differential slides were not used beyond the expiration dates from 5/31/2023 to date of survey. Findings include: 1. On the day of the survey, 10/22 /2025 at 11:56 am, observation during the laboratory tour revealed the following 2 of 3 expired reagents currently being used to prepare manual microscopic hematology differential slides from 11/16/2023 to 10/22/2025: - 1 opened bottle of Three step solution B (Lot #142352, expired 5/10/2025). - 1 opened bottle of Three step solution A (Lot # 118847, expired 5/31/2023). 2. The laboratory performed 979 manual microscopic hematology differential examinations from 11/14/2024 to 10/21/2025. 3. GS#3 confirmed the findings above on 10/22/2025 at 2:35 pm. **Repeat deficiency** D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). -- 4 of 14 -- (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: A. Based on record review, lack of documentation, and interview with Technical Supervisor (TS) #3, the laboratory failed to establish and verify performance specifications before reporting patient test results when modifying an FDA-cleared /approved test system for body fluid (BF) chemistry examinations performed on 2 of 2 Siemens Vista chemistry analyzers from 11/16/2023 to 10/21/2025. Findings include: 1. On the day of survey, 10/21/2025 at 10:45 pm, review of the Siemens Vista procedures revealed the laboratory performed the following chemistry tests on 2 of 2 Siemen's Vista chemistry analyzers using BF specimens from 11/16/2023 to 10/21 /2025. -Albumin (Alb) -Amylase (Amy) -Bilirubin (Bili) -Cholesterol (Chol) - Creatinine (Cre) -Glucose (GLU) -Lactate dehydrogenase (LDH) -Total Protein (TP) - Triglyceride (Trig) -Urea Nitrogen (BUN) -Uric Acid (UA) 2. Further review of the Siemens Vista manufacturer's instructions for use revealed the following: -Alb: "Recommended specimens: serum and plasma(lithium and sodium heparin). " -Amy: "Recommended specimen types: serum and plasma (lithium heparin) and urine." -Bili: "Recommended specimen types: serum and plasma (lithium heparin and EDTA)." - Chol: "Recommended specimen types: serum and plasma (lithium heparin)." -Cre: "Recommended specimen types: serum and plasma (lithium heparin) and urine." - Glu: "Recommended specimen types: serum, plasma(lithium heparin, sodium heparin, and sodium fluoride), urine and CSF." - LDH: "Recommended specimens: serum and plasma(lithium and sodium heparin). " - TP: "Recommended specimen types: serum and plasma (lithium heparin)." -Trig: "Recommended specimen types: serum and plasma (lithium heparin)." -BUN: "Recommended specimen types: serum and plasma (lithium heparin) and urine." -UA: "Recommended specimen types: serum and plasma (lithium heparin) and urine." 3. The laboratory failed to provide documentation for the performance specifications established and verified when performing BF chemistry examinations on 2 of 2 Siemen's Vista chemistry analyzers from 11/16/2023 to 10/21 /2025. 4. TS #3 confirmed the findings above on 10/21/2025 at 1:30 pm. B. Based on record review, lack of documentation, and interview with General Supervisor (GS) #3, the laboratory failed to establish performance specifications before reporting patient test results when modifying an FDA-cleared/approved test system for platelet count (PLT) examinations performed on 2 of 2 Sysmex XN3000 hematology analyzers using sodium citrate anticoagulant from 11/16/2023 to 10/21/2025. Findings include: 1. Review of the Sysmex XN 3000 manufacturer's instructions for use stated, "Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended." 2. On the day of the survey, 10/21/2025 at 02:15 pm, the laboratory failed to provide documentation for the performance specifications established when performing PLT counts using sodium citrate anticoagulant (blue top tube) on 2 of 2 Sysmex XN3000 hematology analyzers from 11/16/2023 to 10/21/2025. 3. GS #3 confirmed the findings above on 10/21/2025 at 4:30 pm. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. -- 5 of 14 -- This STANDARD is not met as evidenced by: Based on lack of maintenance records, and interview with the Administrative Director (AD), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 3 of 3 traceable thermometers used to ensure acceptable storage and operating temperatures were met in the hematology /urinalysis departments from 01/01/2024 to 12/31/2024. Findings include: 1. The laboratory failed to provide documentation of maintenance and function checks performed for the following 3 of 3 traceable thermometers used to monitor refrigerator, room, and heat block temperatures in the hematology/urinalysis departments for 2024: - Room Temperature thermometer (s/n 42573) - Heat block thermometer (s/n 4285) - Refrigerator thermometer (s/n 22221) 2. The AD confirmed the above findings on 10/22/25 at 3:00 pm. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 review of calibration verification (Cal Ver) records and interview with General Supervisor (GS) #1, the laboratory failed to perform calibration verification at least every six months as required for 2 of 2 Siemens Dimension Vista 1500 routine chemistry analyzers from 11/14/2023 to 10/21/2025. Findings include: 1. On the date of survey, 10/21/2025 at 11:00, review of laboratory records for Cal Ver revealed the laboratory failed to ensure the calibration verifications for 2 of 2 Siemens Dimension Vista 1500 chemistry analyzers were performed at least every 6 month for the followning from 11/16/2023 to 10/21/2025. - Siemnens Dimension Vista 1500 (1): Cal Ver performed: February 2024-December 2024 (10 months) - Siemnes Dimension Vista 1500 (2): Cal Ver performed: 2/2024-12/2024 (10 months) 12/2024-8/2024 (8 months) 2. GS #1 confirmed the finding above on 10/21/2025 at 1:00 pm. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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 -- 6 of 14 -- 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with General Supervisor (GS) #6, the laboratory failed to perform QC procedures as required for activated clotting time (ACT) testing performed on 9 of 9 ITC Hemochron Signature Elite analyzers and hemostasis testing performed on 2 of 2 Haemonetics TEG 6s analyzers at least once each day of patient testing from 11/16/2023 through the date of survey. Findings include: 1. On the day of survey, 10/21/2025 at 03:00 pm, review of the laboratory's QC records revealed the laboratory failed to ensure QC was performed at least once each day of testing for the following tests from 11/16/2023 to 10/21/2025: - ACT: 9 of 9 ITC Hemochron Signature Elite (SN 3360, 19905, 21647, 21648, 3591, 3570, 3927, 21683, 22235) - TEG Global Hemostasis/Platelet Mapping: 2 of 2 Haemonetics TEG 6s (SN T1-18E0101120 and T1-18E-101121) 2. Further review of QC records revealed the laboratory performed external QC for ACT and hemostasis testing monthly. The laboratory failed to provide an Individualized Quality Control Plan (IQCP). 3. GS #6 confirmed the findings above on 10/21/2025 at 03:30 pm.. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records and interview with General Supervisor (GS) #5, the laboratory failed to ensure positive and negative staining reactivity was checked and documented each time of use when immunohistochemical (IHC) stains for microscopic histopathology examinations were performed for 2 of 2 years from 11/16/2023 to 10/22/2025. Findings include: 1. On the day of the survey, 10/22/2025 at 10:00 am, review of the laboratory's QC records revealed the laboratory failed to document the positive and negative staining reactivity checked each time of use when IHC stains for microscopic histopathology examinations were performed for 2 of 2 years from 11/16/2023 to 10/21/2025. 2. GS #5 confirmed the findings above on 10/22/2025 at 12:30 pm. **Repeat Deficiency** 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 -- 7 of 14 -- results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: A. Based on record review, lack of documentation, and interview with General Supervisor (GS) #2, the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instruments for 2 of 2 Siemens Dimension Vista 1500 chemistry analyzers used to perform routine chemistry testing in 2025. Findings include: 1. On the day of the survey, 10/21/2025 at 11:30 am, the laboratory failed to provide documentation to evaluate the relationship between different chemistry methodologies/instruments performed for 2 of 2 Siemens Dimension Vista 1500 (SN DV31145 and DV350105) used for routine chemistry examinations in 2025. 2. GS # 1 confirmed the findings above on 10/21/2025 at 1:00 pm. B. Based on record review, lack of documentation, and interview with General Supervisor (GS) #3, the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instruments for 2 of 2 Sysmex XN 3000 hematology analyzers used from 11/16/2023 to 10/21/2025. Findings include: 1. On the day of the survey, 10/21/2025 at 01:30 pm, the laboratory failed to provide documentation for the evaluation performed twice a year for 2 of 2 Sysmex XN 3000 analyzers (XN 14182 and XN14167) to monitor and evaluate the relationship between methodologies/instruments used for the following hematology examinations performed from 11/16/2023 to 10/21/2025: - EDTA vs Sodium Citrate tubes for Platelets 2. GS # 3 confirmed the findings above on 10/21/2025 at 03:30 pm. **Repeat Deficiency** D5783

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 organization, American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the routine chemistry analyte Sodium (Na). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 proficiency testing (PT) organization, American Proficiency Institute (API), the laboratory failed to achieve an overall testing score of satisfactory performance for the routine chemistry analyte: Sodium (Na). The laboratory had unsatisfactory scores for the 1st and 3rd event of 2024. Findings include: Subspecialty Year Event Score Na 2024 1 60% Na 2024 3 60% -- 2 of 2 --

Summary Statement of Deficiencies D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, immunohematology records, and interview with the Laboratory Admin Director (LAD) and General Supervisor (GS) #7 (CMS 209), the laboratory failed to document all transfusion related activities performed on 11/02/2023, and 10/13/2022. Finding include: 1. The laboratory's Blood administration and Transfusion Reactions procedure states: "Record vital sign pre transfusion, at 15 minutes, then hourly until completion of transfusion. Vital signs will also be taken 1 hour post transfusion." 2. On the day of survey, 11/16/2023 at 9:07 am, review of the blood transfusion flow chart revealed the laboratory failed to document the following vitals for 2 of 4 patient reviewed that received a transfusion of red blood cells and had transfusion reactions: - Patient's vital signs after the transfusion reaction started for the event on 10/13/2022. -Missing stop time and 15 minutes vital sign pre transfusion for the event on 11/02/2023. 3. GS #7 confirmed the findings above on 11/16/2023 at 11:30 am. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Based on review of the laboratory's competency assessment records and interview with the Regulatory Director (RD), and Laboratory Admin Director (LAD), the laboratory failed to establish a competency assessment procedure to assess the competency of 5 of 6 technical consultant (TC) and 3 of 11 General Supervisor (GS) for their supervisory responsibilities performed in 2022 and 2023. Findings include: 1. The laboratory could not provide a competency assessment procedure to assess TS and GS for their supervisory responsibilities. 2. On the day of the survey, 11/14/2023 at 11:45 am, a review of laboratory's competency records revealed that the laboratory failed to perform a competency assessment for the 5 of 6 TC (CMS 209 TC #2, #3, #4, #5, #6) and 3 of 11 GS (CMS 209 GS #2, #3, and #4) for their supervisory responsibilities performed in 2022 and 2023. 3. The RD and LAD confirmed the findings above on 11/15/2023 at 06:45 pm. 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 lack of documentation and interview with the Laboratory Director (LD) and Technical Supervisor #2 (TS), the laboratory failed to verify twice annually the accuracy of Hematology and Histopathology examinations performed in 2022 and 2023. Findings include: 1. On the days of survey, 11/14/2023 and 11/15/2023 the laboratory could not provide documentation of the bi-annual verification of accuracy for 2022 and 2023 for the following: - synovial crystals microscopic examinations. - grossing and inking macroscopic examinations. - Immunohistochemical (IHC) microscopic examinations. - Hematoxylin and Eosin (H&E) microscopic examinations. 2. LD and TS #2 confirmed the findings above on 11/15/2023 around 06:30 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) and the College of American Pathologist (CAP) proficiency testing (PT) records and interview with Technical Supervisor (TS) #2, the laboratory failed to document the evaluation and verification activities for PT testing performed in microbiology, chemistry, cytology, hematology/coagulation, and immunology/immunohematology from 09/17/2020 to the date of the survey. Findings Include: 1. On the day of the survey, 11/14/2023 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 D0000 A focused unannounced complaint survey was held on July 28, 2022 and July 29, 2022 based on repeated proficiency testing failures for blood gas analytes. 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: Refer to D2006, D2011, and D2015. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interviews the laboratory failed to rotate testing personnel, with 2 of 27 testing personnel performing PT (proficiency testing) in the past 3 of 6 regulatory PT cycles and 2 of 2 PT off-cycle events for blood gas analytes. Findings: 1. The laboratory's policy "Proficiency Testing," states: "Proficiency testing samples are rotated among the staff who perform patient testing." 2. Based on a review of the "Penn Highlands DuBois pO2 Proficiency Testing and Solution Pack Details" document TP#1 performed two regulatory testing events: API 2021 2nd Event, CAP 2022 1st event, and two off-cycle events: CAP 2021 2ND event and CAP 2021 3rd event. TP#2 performed API 2021 3rd event. 3. Twenty-seven personnel are trained to perform testing on blood gas analytes, based on the indication of personnel on the CMS 209 by TP#2. D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on interview and record review, the laboratory failed to ensure that inter- laboratory communications did not take place pertaining to the results of proficiency testing samples. Findings: 1. During the survey on 7/28/2022, TP#2 explained that testing personnel commonly rotated between separate CLIA sites falling under the same hospital system. When asked how the laboratory ensures that the same PT events are not run by the same testing personnel at separate sites TP#2 explained that he has run the previous PT event at two CLIA separate sites. 2. During record review, College of American Pathologist Event 2 2022 SO-B and AQ-B had been both documented as run by the same testing personnel at Penn Highlands Du Bois and Penn Highlands Clearfield (CLIA 39D0185151). D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on a lack of documentation and interview, the laboratory failed to maintain attestation statements and analyzer printouts for 3 of 6 regulatory PT events reviewed. Findings: 1. The laboratory's policy titled "Proficiency Testing" states: " All records of proficiency testing are maintained for at least two years from the date of participation. The following records are kept: each proficiency testing result, test handling, preparation, processing, examination, each step in the testing, signed attestation statement(s) provided by the proficiency program, a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results,