Penn Highlands Elk

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation and interview with the Laboratory Administrative Director (LAD), the laboratory failed to verify at least twice annually the accuracy of Microbiology/Bacteriology testing performed for 2 of 2 years from 04 /18/2023 to 05/07/2025. Findings include: 1. On the day of survey, 05/06/2025 at 12: 37 pm, review of the laboratory's API PT records revealed the laboratory failed to verify the accuracy at least twice annually of the following examinations performed for Microbiology/Bacteriology in 2023 and 2024 for which compatible PT samples were not offered by API: 2023 and 2024: - Blood culture - CSF culture - Ear/Eye culture - Throat culture 2024: - Gram stain morphology - N. gonorrhoeae culture GCB 2. The laboratory reported an estimated annual volume of 24,440 for microbiology (CMS 116). 3. The LAD confirmed the above findings on 05/07/2025 at 10:58 am. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal 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 -- values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, verification of performance specifications records, lack of documentation, and interview with the Laboratory Administrative Director (LAD), the laboratory failed to provide complete validation records for the required performance specifications for Chemistry and Hematology testing performed on 1 of 1 iSed Elite(SN 5732) erythrocyte sedimentation rate(ESR) analyzer and 2 of 2 Rapidpoint 500e(SN 55349 and 55442) blood gas analyzers before reporting patient results. Findings Include: 1. On the day of survey, 5/6/2025 at 10:30 am, the laboratory could not provide documentation of a reference range/normal value study appropriate for the laboratory's patient population for the following analyzers used for ESR examinations and Blood gas analyses. 1 of 1 iSed Elite SN 5732 2 of 2 Rapidpoint 500e SN 55349 and 55442 2. The LAD confirmed the above findings on 5 /7/2025 at 8:30 am. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) (e)(4)(iv) An approved

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: A. Based on review of the laboratory's procedures, competency assessment records and interview with technical supervisor (TS) #2, the laboratory failed to follow their competency assesment procedure to assess the competency of 7 of 8 Technical supervisors (TS), 4 of 10 technical Consultants (TC) and 1 of 4 general supervisors (GS) for their supervisory responsibilities in 2021 . Findings include: 1. The laboratory's competency assesment procedure states: " The supervisor competency record will be completed annually by the laboratory director for each employee acting as a TC, TS, or GS. 2. On the day of the survey, 04/18/2023 at 8:30 am, the laboratory could not provide documentation for the competency assessment of the following in 2021: - 7 of 8 TS (CMS 209 personnel #2, #3, #4, #5, #6 , #9, and #16). - 4 of 10 TC (CMS 209 personnel #7, #8, #10, and #12) - 1 of 4 GS (CMS 209 Personnel #15) 3. The TS#2 confirmed the findings above on 04/20/2023 around 12:00 pm B. Based on review of the laboratory's procedures, competency assesment records and interview with the technical supervisor (TS) #2, the laboratory failed to follow their competency assesment procedure to assess the competency of 18 of 18 testing personnel (TP) who performed potassium hydroxide (KOH) and wet mounts microscopic examinations from 04/07/2021 to the date of survey. Finding Include: 1. The laboratory's competency assesment procedure states:"Element of competency includes: - "Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; - Monitoring the recording and reporting of test results; -Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; - 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 -- Direct observations of performance of instrument maintenance and function checks; - Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and - Assessment of problem solving skills." 2. On the day of survey 04/19/2023 at 09:20 am, Review of competency assessment reports for (KOH) and Wet mounts microscopic examinations were missing the following 5 of 6 procedures in the assessment for 18 of 18 TP: - Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; - Monitoring the recording and reporting of test results; - Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; - Direct observations of performance of instrument maintenance and function checks; - Assessment of problem solving skills 3. The TS#2 confirmed the finding above on 04/20/2023 around 12:00 pm 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 American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Supervisor (TS)#2, the laboratory failed to evaluate the accuracy of the non graded results obtained for 2 of 3 API events in 2021 and 1 of 3 API events in 2022 in Microbiology. Findings Include: 1. On the day of survey, 04/19/2023 at 09:45 am., review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following analytes in microbiology that were not graded by the PT agency: - API 2021 (2nd Event): Blood Culture MIC/zone Diameter and interpretation of susceptibilities, Urine Culture MIC /zone diameter - API 2021 (3rd Event): Urine Culture MIC/zone diameter - API 2022 (1st Event): Gram stain (GS-05). 2. The laboratory's annual volume for microbiology is 15285 (CMS116) 3. TS#2 confirmed the findings above on 04/20/2023 around 12: 00 pm. 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 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 the laboratory observations, review of temperature records and interview with Technical Supervisor (TS) #2, the laboratory failed to document daily room temperatures in hematology where instruments and supplies were stored from 04/07 /2021 to the day of survey. Findings Include: 1. On the day of survey , 04/20/2023 at -- 2 of 4 -- 10:50 am., During the laboratory tour it was observed that the temperature in Hematology was colder than the temperature in the coagulation department. The thermometer to record room temperatures was located in the coagulation department 2. Record review revealed that the room temperature for hematology and coagulation were taken only in the the coagulation department. 3. The laboratory could not provide separate room temperature records for the hematology department. 4. The TS #2 confirmed the findings above on 04/20/2023 around 12:00 pm. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of validation records, review of the laboratory's validations procedures and interview with the Technical Supervisor (TS)#2, the laboratory failed to establish criteria for acceptable performance specifications for 1 of 1 analytes on the Siemens Vista 500 chemistry analyzers, 3 of 3 analytes on the Siemens Centaur analyzers, 2 of 2 Siemens Rapid Point 500 blood gas analyzers, 2 of 2 Sysmex XN10 hematology analyzers, and 1 of 1 analytes in microbiology in 2021 and 2022. Findings Include: 1. On the days of the survey, 04/18/2023, 04/19/2023 and 04/20 /2023, review of the validation records revealed the following validations did not include criteria for acceptable precision, accuracy and reportable ranges: - 1 of 1 analytes on the Siemens Vista 500 chemistry ( high sensitivity troponin) validation done in 2021 - 3 of 3 analytes on the Siemens Centaur analyzers ( Estradiol, Luteinizing hormone (LH), Follicle-stimulating hormone (FSH)) Validation done in 2021 - 2 of 2 Sysmex XN10 hematology analyzers validations done in 2022 2. The laboratory could not provide the acceptance criteria for the 1 of 1 qualitative microbiology analytes (campylobacter antigen) validation done in 2022. 3. The laboratory could not provide acceptance criteria for when they relocated 2 of 2 Siemens Rapid Point 500 blood gas analyzers in 2022. 4. The laboratory could not provide a complete procedure for validations of new instruments, analytes, methodology and relocation of instruments. 5. The TS#2 confirmed the findings above on 04/20/2023 around 12:00 pm. 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plans (IQCP) and interview with the Technical Supervisor (TS)#2, the laboratory failed to include 1 of 3 parts for IQCP's established in Microbiology, hematology, and immunology when implementing an individualized quality control plan from 04/07/2021 to the days of survey. Findings include: 1. On the days of the survey, 04/18/2023, 04/19/2023 and 04 /20/2023, review of the laboratory's individualized quality control plans revealed that the laboratory failed to include a Quality Control Plan (QCP) which is 1 of 3 parts of an IQCP for the following tests: - Leuko EZ vue - Shiga toxin - Qiastat- dx - Mononucleosis. - Campyplobacter Antigen. 2. Record review revealed that the quality control plan referred to manufacturer's' instructions which state to follow federal, state and local regulations. 3. The TS#2 confirmed the findings above on 04/20/2023 around 12:00 p.m. 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 comparison studies records and interview with the Technical Supervisor (TS)#2, the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instruments in hematology, chemistry, and coagulation from 04/07/2021 to the date of the survey. Findings include: 1. On the days of the survey, 04/18/2023, 04/19/2023 and 04/20/2023, the laboratory failed to provide documentation of the biannual comparison studies for the following instrumentation: 2021: - One comparison study for 2 of 2 Siemens Vista 500 #1 analyzers in chemistry. - Two comparison studies for 2 of 2 Rapid Point 500 blood gas analyzers - Two comparison studies for 2 of 2 ACL top 350 analyzers in coagulation - One comparison study between automated differential and manual differential in hematology 2022: - One comparison study for 2 of 2 ACL top 350 analyzers in coagulation - Two comparison studies between automated differential and manual differential in hematology 2. Results of comparison studies were not reviewed and signed by the laboratory director or designee for the following instrumentation: - 2 of 2 Siemens Vista 500 in October 2021, June 2022 and December 2022. - 2 of 2 Rapid Point 500 #1 in May 2022 and October 2022. 3. TS#2 confirmed the findings above on 04/20/2023 around 12:00 pm. -- 4 of 4 --

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 competency procedure and interview with general supervisor (GS) #3, the laboratory failed to follow their written procedure to assess 17 of 24 testing personnel (TP) for each individual test system they performed testing on in 2019 and 2020. Findings include: 1. The laboratory's competency procedure, point #3 states, "Competency assessment must include all six elements described below for each individual of each test system during each assessment period, unless an element is not applicable to the test". 2. On the day of survey, 04/06/2021, the laboratory was unable to provide competency assessment records for 17 of 24 TP, including all six elements for each test system a TP performed testing on in 2019 and 2020. 3. The GS #3 confirmed the findings above on 04/06/2021 around 3:45 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) 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 -- 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 D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview of the Medical Laboratory Director (MLD) and the Laboratory Administrative Director (ALD) at the time of complaint investigation, Pennhighland Elk laboratory failed to ensure that the phlebotomist and radiology technician collecting patient specimens at the offsite collection facility were trained and competent before conducting blood draws at the Saint Marys Community Medical Building (SMCMB). Findings Include: 1. The Phlebotomist involved in the 03/21 /2018 patient misidentification incident at SMCMB is leased by Penn Highlands Elk. 2. All laboratory specimens collected at the SMCMB are sent to Penn Highlands Elk. 3. The laboratory could not provide any training or competency evaluation records performed by Penn Highlands Elk for 2 laboratory staff (phlebotomist and radiology technician) involved in the patient misidentification incident that occurred on 03/21 /2018 4. The MLD and ALD interviewed on 07/30/2018 at 3:00 PM confirmed that 2 of 2 laboratory staff involved in the patient misidentification incident were not trained by Penn Highlands Elk. 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 -- D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on observation, review of manuals and interview of the phlebotomist and radiology technician at the time of complaint investigation, the laboratory failed to ensure that an approved blood draw procedure was available to the Penn Highlands Elk staff at the off site collection facility (SMCMB). Findings Include: 1. At the time of complaint Investigation on July 30, 2018, the surveyors requested the Penn Highland Elk blood draw procedure from the phlebotomist who registered the complainant on 3/21/2018 and the radiology technician. They could not provide the Penn Highlands Elk Blood Draw Procedure. 2. The phlebotomist interviewed at 02:45 PM on 07/30/2018 confirmed that there was no Penn Highlands Elk Blood Draw Procedure manual onsite. -- 2 of 2 --