Mcgovern Allergy & Asthma Clinic, Pa

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 11, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory failed 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 -- to achieve satisfactory performance for two of two consecutive testing events for the analytes RBC, HCT, HGB, WBC Count, and Platelets, resulting in an initial unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory failed to achieve satisfactory performance for two of two consecutive testing events in 2024 for the analytes RBC, HCT, HGB, WBC Count, and Platelets. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for the analytes RBC, HCT, HGB, WBC Count, and Platelets for two consecutive testing events: 2024 AAB/MLE 2nd event 0% 2024 AAB/MLE 3rd event 0% 2. Based on review of the American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory received the following unsatisfactory performances for the analytes RBC, HCT, HGB, WBC Count, and Platelets for two consecutive testing events: 2024 AAB/MLE 2nd event 0% 2024 AAB/MLE 3rd event 0% Key: RBC = Red Blood Cell HCT = Hematocrit HGB = Hemoglobin WBC Count = White Blood Cell Count D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory failed to achieve satisfactory performance for two of two consecutive testing events for the Hematology specialty in 2024. The findings included: 1. Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for the Hematology specialty for 2 consecutive testing events: 2024 AAB/MLE 2nd event 0% 2024 AAB/MLE 3rd event 0% 2. Based on review of the American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory received the following unsatisfactory performances for the Hematology specialty for 2 consecutive testing events: 2024 AAB/MLE 2nd event 0% 2024 AAB/MLE 3rd event 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for two of two consecutive testing events for the analytes RBC, HCT, HGB, WBC Count, and Platelets, resulting in an initial unsuccessful performance. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 11, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory failed 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 -- to achieve satisfactory performance for five of seven testing events for the analyte Cell ID or WBC Diff, resulting in a non-initial unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory failed to achieve satisfactory performance for five of seven events from 2021 to 2024 for the analyte of Cell ID or WBC Diff. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for Cell ID or WBC Diff for five of seven events: 2021 AAB/MLE 3rd event 40% 2022 AAB/MLE 2nd event 60% 2022 AAB/MLE 3rd event 0% 2024 AAB/MLE 2nd event 0% 2024 AAB/MLE 3rd event 0% 2. Based on review of the American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory received the following unsatisfactory performances for Cell ID or WBC Diff for five of seven events: 2021 AAB/MLE 3rd event 40% 2022 AAB/MLE 2nd event 60% 2022 AAB/MLE 3rd event 0% 2024 AAB/MLE 2nd event 0% 2024 AAB/MLE 3rd event 0% Key: Cell ID = Cell Identification WBC Diff = White Blood Cell Differential 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Association of Bioanalysts/Medical Laboratory Evaluation proficiency reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for five of seven testing events for the analyte Cell ID or WBC Diff, resulting in a non-initial unsuccessful performance. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced survey for initial certification was performed on 12/7/23. The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and testing of [proficiency testing] samples; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; 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: Based on a review of the laboratory's AAB- Medical Laboratory Evaluation proficiency testing records and staff interview, the laboratory failed to have documentation of participating in a proficiency testing program for three of three regulated analytes included in the Complete Blood Count (CBC) in 2023. (Refer to D2004) D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different 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 -- program and must notify CMS before any change in designation; This STANDARD is not met as evidenced by: Based on a review of the laboratory's AAB- Medical Laboratory Evaluation proficiency testing records and staff interview, the laboratory failed to have documentation of participating in a proficiency testing program for three of three regulated analytes included in the Complete Blood Count (CBC) in 2023. Findings include: 1. A review of the laboratory's AAB- Medical Laboratory Evaluation records revealed the laboratory failed to provide documentation of participating in a proficiency testing program for the following analytes included in the CBC for 2023: - Red Blood Cell - Hematocrit - Platelet 2. In an interview on 12/7/23 at 9:35 a.m. in the conference room, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the Sysmex XP-300 Instructions for Use, a review of the laboratory's patient test records, and staff interview, the laboratory failed to ensure patient's results were rerun when analytes were flagged for seven of twenty patient test records reviewed from November 2023. Findings include: 1. A review of the Sysmex XP-300 Instructions for Use (AU553517, 10/2015) revealed the following: "When histogram flags are displayed, perform analysis again." 2. A review of patient's test records from November 2023 the following 7 patients were tested on the Sysmex XP-300 hematology analyzer and the laboratory failed to have documentation of rerunning the patient specimen: - Patient ID: 268981 Tested on 11/1/23 AG flag on Platelet count - Patient ID:265413 Tested on 11/2/23 AG flag on Platelet count - Patient ID: 251394 Tested on 11/6/23 AG flag on Platelet count - Patient ID: 275697 Tested on 11/8/23 AG flag on Platelet count - Patient ID: 268708 Tested on 11/27/23 AG flag on Platelet count - Patient ID: 266855 Tested on 11/29/23 AG flag on Platelet count - Patient ID: 266002 Tested on 11/30/23 AG flag on Platelet count 3. In an interview on 12/7/23 at 10:40 a.m. in the conference room, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on a review of the laboratory's annual competency assessments and staff -- 2 of 4 -- interview, the technical consultant failed to assess test performance through testing previous specimens, blind test samples, or external proficiency testing samples for one of one annual competency assessment performed for Complete Blood Count (CBC) testing on the Sysmex XP-300 hematology analyzer in 2023. Findings include: 1. A review of the laboratory's annual competency assessments performed in 2023 revealed the technical consultant failed to assess test performance through testing previous specimens, blind test samples, or external proficiency testing samples for testing person #1 for CBC testing on the Sysmex XP-300 hematology analyzer. 2. In an interview on 12/7/23 at 9:25 a.m. in the conference room, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on a review of the laboratory's annual competency assessments and staff interview, the technical consultant failed assess problem solving skills for one of one annual competency assessment performed for Complete Blood Count (CBC) testing on the Sysmex XP-300 hematology analyzer in 2023. Findings include: 1. A review of the laboratory's annual competency assessments performed in 2023 revealed the technical consultant failed to assess problem solving skills for testing person #1 for CBC testing on the Sysmex XP-300 hematology analyzer. 2. In an interview on 12/7 /23 at 9:25 a.m. in the conference room, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's personnel records and staff interview, the laboratory failed to have documentation of education for one of one testing person to perform moderate complexity testing in 2023. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have -- 3 of 4 -- successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of education for one of one testing person to qualify them to perform moderate complexity testing on the Sysmex XP-300 hematology analyzer in 2023. Findings include: 1. A review of the CMS 209 form revealed one testing person who performed moderate complexity testing on the Sysmex XP-300 hematology analyzer. 2. A review of the laboratory's personnel records revealed the laboratory failed to have documentation of education for testing person #1. 3. In an interview on 12/7/23 at 9: 15 a.m. in the conference room, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. -- 4 of 4 --