East Penn Mfg Co Inc Clinical Lab

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 record review, lack of documentation, and interview with the Clinical Lab Coordinator (CLC), the laboratory failed to follow procedures to assess the competency of 1 of 1 Technical Supervisors (TS) for their supervisory responsibilities when toxicology testing was performed from 07/24/2024 to 03/17/2026. Findings Include: 1. The laboratory's Competency Assessment policy stated, "The Laboratory Director is responsible for performing and documenting competency assessments for the Technical and General Supervisors." 2. On the date of the survey, 03/17/2026 at 9: 42 am, the laboratory failed to provide a competency assessment reviewed by the Laboratory Director to assess the competency of 1 of 1 TS (Personnel #2, CMS 209, dated 03/17/2026) for their supervisory responsibilities when toxicology testing was performed in the laboratory from 07/24/2024 to 03/17/2026. 3. Review of the laboratory's Blood Sample Report revealed the laboratory performed 26,625 Toxicology examinations from 07/24/2024 to 03/17/2026. 4. The CLC, (CMS 209 personnel #4, dated 03/17/2026), confirmed the above findings on 03/17/2026 at 1:00 pm. D5301 TEST REQUEST CFR(s): 493.1241(a) (a) The laboratory must have a written or electronic request for patient testing from an authorized person. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on record review, lack of documentation and interview with the Clinical Lab Coordinator (CLC), the laboratory failed to have written or electronic requests from an authorized person for toxicology patient testing performed for 2 of 2 years from 07 /24/2024 to 03/17/2026. Findings include: 1. On the date of the survey, 03/17/2026 at 10:30 am, the laboratory could not provide written or electronic test requisitions from an authorized person for Lead and Zinc Protoporphyrin (toxicology) testing performed for 2 of 2 years from 07/24/2024 to 03/17/2026. 2. Review of the laboratory's Blood Sample Report revealed the laboratory performed 26,625 Toxicology examinations from 07/24/2024 to 03/17/2026. 3. The CLC, (CMS 209 personnel #4, dated 03/17 /2026), confirmed the above findings on 03/17/2026 at 1:00 pm. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 lack of documentation and interview with Testing Personnel (TP #1), the laboratory failed to perform calibration verification at least once every six months for the Helena Laboratories Protofluor Z Chemistry Analyzer from 06/24/2022 to 09/28 /2022. Findings include: 1. On the date of survey, 09/28/2022 at 10:30 am, the laboratory could not provide calibration verification records for the Helena 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 -- Laboratories protoflour Z for Zinc protoporphyrin testing from 06/24/2020 to 09/28 /2022. 2. TP #1 confirmed the finding above on 09/28/2022 around 11:00 am. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with the testing personnel (TP)#1, the Technical Supervisor (TS) failed to perform direct observations of specimen handling, processing and testing for 3 of 3 testing personnel (TP) who performed Toxicology test from 06/24/2020 to the day of survey. Findings Include: 1. On the day of survey, 09/28/2022 at 09:42 am., review of competency assessment records revealed that direct observations of specimen handling, processing and testing were not included in the competency assessment records for 3 of 3 TP (CMS 209 personnel # 4, #5, and #6) who performed lead and zinc protoporphyrin testing from 06/24/2020 to 09/28/2022. 2. The TP#1 confirmed the finding above on 09/28/2022 around 11:00 a.m. D6124 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on review of competency assessment records and interview with the testing personnel (TP)#1, the Technical Supervisor (TS) failed to perform direct observation of performance of instrument maintenance and function checks for 3 of 3 testing personnel (TP) who performed Toxicology test from 06/24/2020 to the day of survey. Findings Include: 1. On the day of survey, 09/28/2022 at 09:42 am., review of competency assessment records revealed that direct observations for performance of instrument maintenance and function checks were not included in the competency assessment records for 3 of 3 TP (CMS 209 personnel # 4, #5, and #6) who performed lead and zinc protoporphyrin testing from 06/24/2020 to 09/28/2022. 2. The TP#1 confirmed the finding above on 09/28/2022 around 11:00 a.m. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) reports and interview with Testing Personnel (TP) #1 and #2, the laboratory failed to maintain copies of Wisconsin State Laboratory of Hygiene (WSLH) attestation statements from 2018 to the day of survey. Findings includes: 1. On the day of survey, 06/24/2020, TP#1 could not provide copies of the attestation statements for WSLH PT result for 2018 event 1, 2 and 3 and 2019 event 1, 2 and 3. 2. Testing Personnel #1 confirmed the finding above on 06/24/2020 around 8:40 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manuals and interview with the testing personnel (TP) #1 and #2, the laboratory failed to follow their competency assessment policy to evaluate the competency of 2 of 2 TP for their 6 month, 12 month, and yearly competency and to establish a policy to access the competency of 3 of 3 regulatory personnel in 2018 to 2020. Findings include: 1. The Competency Assessment Policy states, "For Regular testing personnel, the competency assessment must be performed at least annually. For new hire testing personnel, the competency assessment must be performed at 6 months of employment and again at 12 months of employment. After the first year of employment, the competency assessment can be performed annually". 2. On the day of survey, 06/24/2020, review of laboratory personnel competency assessment records revealed: - TP#2 (hired on 02/2019) was not assessed for 6 month and 12 month competency. - TP#1 was not assessed yearly for competency from 01/09/2019 to 2020. 3. The competency assessment policy reviewed, did not describe how to evaluate the technical supervisor (TS) and general supervisor (GS) for their regulatory responsibilities in the laboratory. 4. 2 of 2 TS and 1 of 1 GS were not assessed for their regulatory responsibilities in the laboratory in 2018, 2019 and 2020. 5. TP#1 confirmed the findings above on 06/24/2020 around 10: 00 am. 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 the laboratory's procedure manuals and interview with testing personnel (TP) #1 and #2, the laboratory failed to establish policies and procedures to assess ongoing mechanism to monitor the laboratory's system from 2018 to the day of survey. Findings include: 1. On the day of survey, 06/24/2020, TP#1 could not provide a quality assessment policy to assess the quality of its laboratory systems from 02/07/2018 to 06/24/2020. 2. The TP#1 confirmed the finding above on 06/24 /2020 around 8:45 am. -- 2 of 2 --