Medi-Help Pc Laboratory

Summary Statement of Deficiencies D0000 A desk review for proficiency testing results was conducted by the Pennsylvania State Agency for Medi-Help PC Laboratory on 07/07/2025. 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 Report 0155D and graded results from the proficiency testing (PT) organization, College of American Pathologists (CAP), 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 the hematology analyte: Hematocrit (HCT). The laboratory had unsatisfactory scores for the 1st and 2nd event of 2025. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 Report 0155D and graded results from the proficiency testing organization, College of American Pathologists (CAP), the laboratory failed to achieve an overall testing score of satisfactory performance for the hematology analyte: Hematocrit (HCT) . The laboratory had unsatisfactory scores for the 1st and 2nd events of 2025. Findings include: 1. Review of the CASPER Report 0155D revealed the following unsatisfactory scores: - 2025 Event 1 HCT: 60% - 2025 Event 2 HCT: 20% 2. Further review of the laboratory's 2025 CAP PT agency's graded results confirmed the above findings resulting in unsatisfactory performance for the hematology analyte: HCT. -- 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 American Proficiency Institute (API) proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to provide 6 of 6 attestation statements for chemistry PT events performed in 2022 and 2023. Findings Include: 1. On the day of the survey, 01/11/2024 at 09:00 am, the laboratory failed provide 6 of 6 API PT attestation statements for the following chemistry testing events in 2022 and 2023: - 2022 Chemistry core - 1st, 2nd, and 3rd event - 2023 Chemistry core - 1st, 2nd, and 3rd event 2. The LD confirmed the finding above on 01/11/2024 at 01:30 pm. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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. 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 -- This STANDARD is not met as evidenced by: Based on a lack of documentation and interview with the laboratory director (LD), the laboratory failed to retain quality control (QC) documents and patient reports for hematology and virology testing performed in 2022 and 2023. Findings include: 1. On the day of the survey, 01/11/2024 at 11:30 am, the laboratory failed to provide patient reports and QC documentation for the following tests performed in the laboratory in 2022 and 2023. - Prothrombin time international normalized ratio- Coag-Sense Professional Prothrombin Time Test (PT/INR). - Influenza A & B- McKesson Consult Influenza A & B Test. - Covid 19-waived- Quidel Quickvue Covid 19. 2. The laboratory performed 2355 waived testing in 2023 (CMS 116). 3. The LD confirmed the findings above on 01/11/2024 at 01:30 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 laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of analytes that were not evaluated or scored for 4 of 18 Urinalysis, hematology, and microbiology PT events in 2022 and 2023. Findings include: 1. On the day of survey, 10/24/2023 at 12:15 PM, review of the laboratory's CAP PT records revealed that the laboratory did not verify the accuracy for the following events that were not graded due to educational challenge in 2022, and 2023: FH2 A 2022 Blood Cell ID- BCP 06, BCP 07, BCP 08, BCP 09, BCP 10 CM A 2023 Clinical Microscopy- CM01, CM 02, CM 03 RMC A 2023 Routine Microbiology combination - UC 01 RMC B 2023 Routine Microbiology Combination UC 06 2. The LD confirmed the findings above on 01/11/2024 at 04:00 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 laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to document the evaluation and verification activities for 1 of 3 PT testing event in hematology in 2022. Findings include: 1. On the day of survey, 01/11/2024 at 09: 45 am, a review of laboratory's CAP PT records revealed that the laboratory did not document the review and

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 American Proficiency Institute (API) proficiency testing (PT) organization, the laboratory failed to successfully participate in proficiency testing for the analyte Total Cholesterol. 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 American Proficiency Institute (API) proficiency testing (PT) organization, the laboratory failed to successfully participate in proficiency testing for the analyte: Total Cholesterol, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 3rd event of 2022, and the 2nd event of 2023. Findings include: Analyte Year Event Score Total Cholesterol 2022 3 0%. Total Cholesterol 2023 2 60%. -- 2 of 2 --

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 American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analytes Chloride and Glucose (non-waived). 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 a 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 a proficiency testing for the Routine Chemistry analytes listed below. The laboratory had unsatisfactory scores for the 1st event of 2022, 2nd event of 2022, and the 3rd event of 2022. Findings include: Analyte Year Event Score% CHLORIDE 2022 2 20 CHLORIDE 2022 3 0 GLUCOSE 2022 1 60 GLUCOSE 2022 3 0 -- 2 of 2 --

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 American Proficiency Institute (API) and College of American Pathologist (CAP) proficiency testing (PT) records and interview with the Laboraotry Director (LD), the Laboratory Director (LD) and Testing Personnel (TP) failed to sign the API and CAP PT attestation statement documents in 2020 and 2021. Findings include: 1. On the day of survey, 02/15/2022 at 12:00 a.m., review of API and CAP PT records revealed, the following attestation statement documents were not signed: API Core Chemistry: - 2020: Event #1, Event#2 and Event #3. - 2021: Event #1, Event#2, and Event#3. CAP: - 2020 Hematology: Event #A and Event#C. - 2020 Clinical Microscopic: Event#A. - 2021 Microbiology: Event#A 3. The LD confirmed the findings above on 02/15/2022 at 04:00 p.m. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. 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 lack of Quality Control documentation and interview with the Laboratory Director (LD), the laboratory failed to document a positive and negative reactivity for Bacitracin (A) Discs each lot/shipment of disks use in 2020 and 2021. Findings include: 1. On the day of survey 02/15/2022 at 1:40 p.m, the laboratory could not provide the records for the porsitive and negative of the Bacitracin (A) Discs from 02 /15/2020 to 02/15/2022. 2. The LD confirmed the finding above on 02/15/2022 at 04: 00 p.m. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on lack of Quality Control documentation and interview with the Laboratory Director (LD), the laboratory failed to document a positive and negative reactivity of the gram stain quality controls (QC) each week of use in 2020 and 2021. Findings include: 1. On the day of survey 02/15/2022 at 12:00 p.m, the laboratory could not provide QC record for gram stain from 02/15/2020 to 02/15/2022. 2. The LD confirmed the finding above on 02/15/2022 at 04:00 p.m. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation during the laboratory, quality control (QC) record review, and interview with the Testing Personnel (TP)#2, the laboratory failed to ensure proper standardization of the inoculum for Antimicrobial Susceptibility QC each day of patient testing from 02/15/2020 to 02/15/2022 Findings Include: 1. Observation on 02 /15/2022, at 03:04 p.m., showed the laboratory did not have proper 0.5 McFarland standardization of the inoculum for Antimicrobial Susceptibility test Quality Control (QC). 2 Record review revealed that that the laboratory performed QC on a weekly basis. 3. On 02/15/2022 TP #2 stated the laboratory takes the colonies and emulsify them in saline, they don't have a standard to compare and just inoculate the plate with the solution. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) -- 2 of 3 -- 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of the Micros 60 hematology analyzer validation records and interview with the Laboratory Director (LD), the Laboratory Director failed to approve the performance specifications of precision and accuracy for hematology analytes performed on the Micros 60 used from 12/16/2021 to 02/15/2022. Finding Include: 1. On the day of survey, 02/15/2022 at 11:30 a.m. record review revealed that the LD did not approve and review the validation for the Micros 60 Analyzer performed on 12/16/2021. 2. The LD confirmed the finding above on 02/15/2022 at 04:00 p.m. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Chloride. 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 a 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 a proficiency testing for the analyte: Chloride, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 2nd event of 2019 and the 3rd event of 2019. Findings include: Analyte Year Event Score Chloride 2019 2 20%. Chloride 2019 3 0%. -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on interview of the Laboratory Director and review of the proficiency test records, at the time of the survey, the laboratory failed to attain a score of at least 80, for1 of 20 analytes in the American Proficiency Institute 2019 2ND testing event. Findings: 1. Chloride proficiency test score, was 20% for the American Proficiency Institute 2019 2ND testing event. 2. During the survey (15:30 10/10/2019), the the Laboratory Director confirmed the above finding. 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 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 Quality Control record review and interview with the Laboratory Staff on (01/25/2018), the laboratory failed to document all Quality Control procedures performed for Urine Sediment examination. Findings include: 1.Quality Control documentation was not found for Urine Sediment Examination tests preformed from January 2017 through the date of survey 25 January 2018. 2. During the survey, the Laboratory Director, confirmed that Quality Control was not documented each day of patient testing for 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 --