Lori Mcauliffe Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lori McAuliffe MD PA on 10/27/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited were as follows: 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: Based on record review and interview, the laboratory failed to monitor the percent humidity of the room where testing was performed using the Cell-Dyn Emerald Hematology analyzer from 11/2024 to 09/2025. Findings included: 1. The Cell-Dyn Emerald Hematology analyzer validation study was reviewed. The analyzer was put into use 11/25/2024. 2. The Cell-Dyn Emerald Operator's Manual with a date of June 2010 was reviewed. The manual documented an operational maximum humidity of 80%. 3. Temperature Logs were reviewed for 02/2025 and 09/2025. There was no documentation that showed the laboratory monitored the percent humidity. 4. An interview with Laboratory Director on 10/27/2025 12:00 to 12:30 p.m. confirmed the above. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) 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 -- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Consultant failed to document and sign off on competency assessments for three of three testing personnel (TP) (TP #A, #B, #E) selected for review. Findings included: 1. TP #A's Job Description and Competency Evaluation Form was reviewed. Their date of hire was 12/27/2021. The records reflected and annual competency was due March 2024 and 2025. There was no annual competency evaluation for 2024 or 2025 completed or signed by the Technical Consultant. 2. TP #B's Job Description and Competency Evaluation Form was reviewed. Their date of hire was 01/02/2022. The records reflected and annual competency was due March 2024 and 2025. There was no annual competency evaluation for 2024 or 2025 completed or signed by the Technical Consultant. 3. TP #E's Job Description and Competency Evaluation Form was reviewed. Their date of hire was 01/20/2025. The initial competency was filled out but was not signed or dated by the Technical Consultant. The Form documented the 1st Review (competency) as 07/14/2025. 4. An interview with the Technical Consultant on 10/27 /2025 from 12:00 to 12:30 p.m. confirmed the above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Lori McAuliffe MD PA on 11/10/21. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review of the procedure manual and competency records, and interview with Testing Personnel (TP) #A, the Technical Consultant failed to perform semi-annual personnel competency for 1 (#D) TP out of 4 (#A-#D) TP for the specialty of hematology for two out of two years reviewed (2019-2021). Findings included: Review of the "Laboratory Staff Orientation, Training, and Assessment" procedure revealed that, "Each employee will be given an evaluation for competency at 6 months from hire and annually thereafter." Review of the Laboratory Personnel Report (Form CMS-209) signed by the Laboratory Director on 11/08/21 revealed the laboratory had four TP (#A-#D). Review of competency records revealed TP #D's personnel file had a "Job Description and Competency Evaluation" which indicated a date of hire of 10/12/20, date of present position as 10/19/20 and a 90 day review date of 01/05/21. No additional competency reviews were present for TP #D. On 11/10/21 at 10:15 am, TP #A, also listed as the "Trainer" on TP #D's 01/05/21 competency evaluation, stated she did not know that personnel competency needed to be performed semi-annually the first year. 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 D0000 An announced CLIA recertification survey was conducted at Lori McAulifffe MD PA on 08/28/19. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review of the CMS 209 Laboratory Personnel Report, laboratory procedure manual, and One World Accuracy Accutest Hematology proficiency testing records for White Blood Cell Count, Red Blood Cell Count, Hemoglobin, Hematocrit, Mean Corpuscular Volume, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, Platelets, Granulocytes, Lymphocytes, and Monocytes, and interview with Testing Personnel #A, the laboratory failed to have all testing personnel (#A, #B, #C, and #D) rotate through the testing of proficiency testing for two out of two (2017-2019) years reviewed. Findings included: Record review of the CMS 209 Laboratory Personnel Report signed by the Laboratory Director on 07/17/19 showed the laboratory had 4 testing personnel ( #A, #B, #C, and #D). Record review of the laboratory's manual revealed "Proficiency Testing" procedure that stated "all staff performing the testing should sign in the attestation spaces provided on the data sheet." Record review of the proficiency testing revealed that Testing Personnel #A had signed the attestation statement for 2 proficiency testing Events (1st Event 2018, and 1st Event 2019) out of 6 ( 3rd Event 2017, 1st, 2nd, and 3rd Event 2018, and 1st and 2nd Event 2019) proficiency test Events. Record review of the proficiency testing also revealed that the 2nd Event of 2019 indicated Testing Personnel #A had performed the proficiency testing but Testing Personnel #A had not signed 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 3 -- attestation statement. Record review of the proficiency testing also revealed that the 3rd Event of 2017 attestation statement had not been signed by the testing personnel. Testing Personnel #A signed the 3rd Event of 2017 attestation statement during the 08 /28/19 survey after being shown the signature was missing. On 08/28/2019 at 10:30 AM, Testing Personnel #A stated she had performed all proficiency testing for two out two years ( 3rd Event 2017, 1st, 2nd, and 3rd Event 2018, and 1st and 2nd Event 2019). She did not know proficiency testing must be rotated through all testing personnel to include Testing Personnel #B, #C, and #D. 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 record review of One World Accuracy Accutest Hematology proficiency testing records, the laboratory procedure manual, and interview with Testing Personnel #A, the laboratory did not maintain all of the proficiency testing records and did not have the required signatures on all of the documentation for two of two years reviewed (2017-2019). Findings include: Record review of the laboratory procedure manual revealed the "Proficiency Testing" procedure stated "The Laboratory Director or Technical Consultant should sign and date the data sheet and all staff performing the testing should sign in the attestation spaces provided on the data sheet." (Attestation statement and signature blanks for laboratory director and testing personnel were present at the bottom of the data sheet.) In addition, the procedure stated "Retain a copy of all data sheets, attestation sheets, worksheets, and instrument printouts for 2 years." Record review of the proficiency testing revealed attestation statements for 3 proficiency testing events (3rd Event 2017, 3rd Event 2018, and 2nd Event 2019) out of 6 ( 3rd Event 2017, 1st, 2nd, and 3rd Event 2018, and 1st and 2nd Event 2019) had not been signed by the Laboratory Director and Testing Personnel. Testing Personnel #A did sign the 2017 3rd Event during the survey on 08/28/19. Record review of the proficiency testing revealed 1 attestation statement (2nd proficiency testing event 2018 ) was missing out of 6 proficiency testing events (3rd Event 2017, 1st, 2nd, 3rd 2018 Event, and 1st and 2nd Event 2019). Interview on 08/28/2019 at 12:15 PM with Testing Personnel #A confirmed the attestation statements had not been signed for 3rd Event 2017, 3rd Event 2018, and 2nd Event 2019 and the attestation statement for 2nd Event 2018 was missing. 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 -- 2 of 3 -- 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 record review and interview with Testing Personnel #A, the laboratory failed to document the humidity for 2 out of 2 years (2017-2019) . Findings Included: Record review of

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 laboratory's proficiency testing records for 2018 and 2019, the laboratory did not have successful performance in proficiency testing for the specialty of routine hematology. Refer to D2130. Findings include: Review of the AccuTest proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on July 22, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, red blood cell count (RBC) for two out of three testing events in 2018 and 2019. D2130 HEMATOLOGY 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 -- CFR(s): 493.851(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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On July 22, 2019 on or about 10:00 AM the AccuTest proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, red blood cell (RBC) count, as shown below. Event #2, 2018 RBC count-60% Event #1, 2019 RBC count-40% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On July 19, 2019, on or about 10:00 AM, the AccuTest proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, red blood cell (RBC) count, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analyte, red blood cell (RBC) count in the specialty of hematology. Findings Include: The review of the AccuTest proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on July 22, 2019 on or -- 2 of 3 -- about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #2, 2018 RBC count-60 % Event #1, 2019 RBC count-40%. -- 3 of 3 --