Kevin G Kelly Md

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, AAB - Medical Laboratory Evaluation (AAB-MLE). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 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 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing in the Specialty of Hematology and White Blood Cell (WBC) Count. The laboratory failed two consecutive PT events in 2024 and 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2130 and D2131. 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for White Blood Cell (WBC) Count resulting in initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Reports 153D and 155D, Individual Laboratory Profile reports, the laboratory received the following failing scores, resulting in unsatisfactory performances for two consecutive events, as follows: A. 2024-Event M3: WBC 60% B. 2025-Event M1: WBC 60% 2. A review of the laboratory's proficiency testing results from AAB-MLE confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(g) (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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing in the Specialty of Hematology, resulting in initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Reports 153D and 155D, Individual Laboratory Profile reports, the laboratory received the following failing scores, resulting in unsatisfactory performances for the Specialty of Hematology for two consecutive events, as follows: A. 2024-Event M3: 60% C. 2025-Event M1: 66% 2. A review of the laboratory's proficiency testing results from AAB-MLE confirmed the above findings. . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from AAB- Medical Laboratory Evaluation (AAB-MLE), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from AAB-Medical Laboratory Evaluation (AAB-MLE), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program in the Specialty of Hematology and White Blood Cell (WBC) Count in two consecutive 2024-2025 AAB-MLE PT events, resulting in initial unsuccessful participation. Refer to D2130 and D2031. -- 3 of 3 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the AAB (American Association of Bioanalysts) proficiency testing (PT) records,

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of the 2019 Hematology quality control (QC) records, a review of the manufacturer's package insert for QC material, a review of the patient test logs for CBCs (Complete Blood Counts), and an interview with Testing Personnel (TP) #1 (newly qualified Technical Consultant), the surveyor determined the laboratory staff used expired quality control (three levels) beyond the expiration date. This affected one month (May) in 2019. The findings include: 1. A review of the Hematology QC records (the instrument printouts) for May 2019 revealed the QC material with lot numbers, #069100 (low), expired on 5/3/2019; #079100 (normal), and #089100 (high) expired on 5/6/2019. The laboratory staff continued to use the QC material from 5/6 /2019 - 6/2/2019. 2. A review of the manufacturer's package inserts for the above mentioned QC confirmed the expiration date of 5/6/2019 for all three levels (The expiration date for the low level was input incorrectly). 3. A review of the patient test logs for CBCs revealed no testing occurred on 5/24/2019 - 6/2/2019. However patient testing occurred on 5/7/2019 - 5/10 (a total of 73 patient CBCs); and 5/13/2019 - 5/16 (a total of 51 patient CBCs). Patient testing also occurred on 5/17, 5/18, 5/20 - 5/23. The QC material used with these patient test runs had expired. 4. In an interview on 12 /19/2019 at 4:03 - 4:30 PM, TP #1 confirmed the manual containing the daily patient test logs were lists of CBCs performed in-house. TP #1 reviewed the QC records and confirmed the use of expired quality control in May of 2019. TP #1 further stated she did not realize the instrument (Act Diff 2) would allow expired QC material to be used. . 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 -- D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the 2018 Hematology quality control (QC) records, a review of the policy and procedure, "CBC MACHINE PREVENTATIVE MAINTENANCE AND CLEANING SCHEDULE," a review of the CBC (Complete Blood Count) patient test logs, the testing personnel's review of the medical records, and an interview with Testing Personnel (TP) #1, the surveyor determined the laboratory proceeded with patient testing when quality controls were not acceptable. This affected two days in June of 2018. The findings include: 1. A review of the 2018 Hematology QC records revealed the laboratory staff failed to ensure at least two levels of quality control were acceptable on 6/17/18, prior to testing patients and reporting the results of the CBCs. On 6/30/18, the background count for Hemoglobin (Hgb) failed; however the staff proceeded with patient testing. 2. A review of the policy and procedure, "CBC MACHINE PREVENTATIVE MAINTENANCE AND CLEANING SCHEDULE," revealed the following: "PURPOSE To ensure quality control standards are met to assure patient sample testing accuracy and precision by ensuring the machine remains in good working order. Startup must be performed each morning and every time the machine is turned off or put through shutdown procedures. ...All startup criteria must "PASS" to proceed EVERY time..." 3. A review of the CBC patient test logs revealed five CBC patient specimens were run on June 17, 2018 and five on June 30. 4. During an interview on 12/19/2019 at 4:03 - 4: 30 PM, TP #1 (also the office manager and newly qualified Technical Consultant) reviewed the medical records for the above mentioned dates and confirmed that all except one patient CBC specimen were tested on June 17 and June 30, when QC was not acceptable. -- 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 reports (#153/#155), a review of American Association of Bioanalysts (AAB) performance evaluations for Hematology, and telephone interviews with the laboratory personnel and an AAB representative, the surveyor determined the laboratory failed Hematocrit (HCT) for three of five testing events, Event #3, 2016; Event #2, 2017; and Event #1, 2018. These failures resulted in non-initial unsuccessful proficiency testing participation for HCT for the laboratory. Additionally, the laboratory's overall Hematology scores for Event #2, 2017 of 42 % and for Event #1, 2018 of 0 % (due to untimely submission), resulted in unsuccessful proficiency testing participation for the specialty. The findings include: 1. Cited on 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 5 -- /16/17, Initial Unsuccessful Proficiency Testing Participation: a) A review of the CASPER reports and the AAB performance evaluations revealed the laboratory scored 60 % (percent) for the HCT for Event #3, 2016 and 20 % for Event #2, 2017, two of three consecutive testing events. These failures resulted in the laboratory's initial unsuccessful proficiency testing performance. b) The above noted findings were confirmed by an AAB representative on 8/16/17 at 12:00 PM, during a telephone interview. 2. A review of AAB proficiency testing evaluations on 8/14/18 revealed the laboratory scored 0 % for HCT for Event #1 of 2018, in addition to the earlier failures; thus resulting in unsuccessful participation for three of five testing events. 3. In a telephone interview on 8/15/18 at 11:05 AM, the testing personnel confirmed the laboratory failed to timely submit the data to AAB for grading for Event #1, 2018, resulting in zero percents scores for all analytes. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER reports (#153/#155), a review of American Association of Bioanalysts (AAB) performance evaluations for Hematology, and a telephone interview with the laboratory personnel, the surveyor determined the laboratory failed Hematology testing for two events, Event #2, 2017 and Event #1, 2018, two of three consecutive testing events. The findings include: 1. The laboratory's overall Hematology scores for Event #2, 2017 of 42 % and for Event #1, 2018 of 0 % (due to untimely submission), resulted in unsuccessful proficiency testing participation for the specialty. 2. By review of AAB proficiency testing evaluations on 8/14/18, the surveyor confirmed the laboratory scored 0 % for Hematology (zero percent scores for all analytes) for Event #1 of 2018, and an overall 42 % for Event #2, 2017 [53 % for the White Blood Cell Differential, 20 % for RBC (Red Blood Cell Count), Hematocrit and Hemoglobin; and 40 % for WBC (White Blood Cell Count)]. 3. In a telephone interview on 8/15/18 at 11:05 AM, the testing personnel confirmed the laboratory failed to timely submit the data to AAB for grading for Event #1, 2018, resulting in zero percents scores for all analytes. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the CASPER reports (#153/#155), a review of American -- 2 of 5 -- Association of Bioanalysts (AAB) performance evaluations for Hematology, and a telephone interview with the laboratory personnel, the surveyor determined the laboratory failed Hematology testing for Event #1, 2018 (zero percent scores for all analytes, failure to participate), due to the laboratory's failure to timely submit the testing results to AAB for grading. The findings include: 1. A review of AAB proficiency testing evaluations on 8/14/18 revealed the laboratory scored 0 % for all analytes for Hematology testing for Event #1 of 2018. 2. In a telephone interview on 8 /15/18 at 11:05 AM, the testing personnel confirmed the laboratory failed to timely submit the data to AAB for grading for Event #1, 2018, resulting in zero percents scores for all analytes (a failure to participate). D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of the CASPER reports (#153/#155), a review of American Association of Bioanalysts (AAB) performance evaluations for Hematology, and a telephone interview with the laboratory personnel, the surveyor determined the laboratory failed Hematology testing for Event #1, 2018, due to the laboratory's failure to submit, within the established timeframe, the testing results to AAB for grading. The findings include: 1. By review of AAB proficiency testing evaluations on 8/14/18, the surveyor confirmed the laboratory scored 0 % for Hematology (zero percent scores for all analytes) for Event #1 of 2018, and an overall 42 % for Event #2, 2017 [53 % for the White Blood Cell Differential, 20 % for RBC (Red Blood Cell Count), Hematocrit and Hemoglobin; and 40 % for WBC (White Blood Cell Count)]. 2. In a telephone interview on 8/15/18 at 11:05 AM, the testing personnel confirmed the laboratory failed to timely submit the data to AAB for grading for Event #1, 2018, resulting in zero percents scores for all analytes. 3. The laboratory's overall Hematology score for Event #1, 2018 of 0 %, due to untimely submission is considered unsatisfactory performance. 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 CASPER reports (#153/#155), a review of American Association of Bioanalysts (AAB) performance evaluations for Hematology, and a telephone interview with the laboratory personnel, the surveyor determined the laboratory failed Hematology testing for two events, Event #2, 2017 and Event #1, 2018, two of three consecutive testing events. The findings include: 1. The laboratory's overall Hematology scores for Event #2, 2017 of 42 % and for Event #1, 2018 of 0 % (due to untimely submission), resulted in unsuccessful proficiency testing participation for the specialty. 2. By review of AAB proficiency testing evaluations on -- 3 of 5 -- 8/14/18, the surveyor confirmed the laboratory scored 0 % for Hematology (zero percent scores for all analytes) for Event #1 of 2018, and an overall 42 % for Event #2, 2017 [53 % for the White Blood Cell Differential, 20 % for RBC (Red Blood Cell Count), Hematocrit and Hemoglobin; and 40 % for WBC (White Blood Cell Count)]. 3. In a telephone interview on 8/15/18 at 11:05 AM, the testing personnel confirmed the laboratory failed to timely submit the data to AAB for grading for Event #1, 2018, resulting in zero percents scores for all analytes. 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 a review of the CASPER reports (#153/#155), a review of American Association of Bioanalysts (AAB) performance evaluations for Hematology, and telephone interviews with the laboratory personnel and an AAB representative, the surveyor determined the laboratory director failed to ensure the laboratory successfully participated in Hematology (Hematocrit) testing for three of five testing events, Event #3, 2016; Event #2, 2017; and Event #1, 2018. These failures resulted in non-initial unsuccessful proficiency testing participation for HCT for the laboratory. Additionally, the laboratory's overall Hematology scores for Event #2, 2017 of 42 % and for Event #1, 2018 of 0 % (due to untimely submission), resulted in unsuccessful proficiency testing participation for the specialty. The findings include: 1. Cited on 8 /16/17, Initial Unsuccessful Proficiency Testing Participation: a) A review of the CASPER reports and the AAB performance evaluations revealed the laboratory scored 60 % (percent) for the HCT for Event #3, 2016 and 20 % for Event #2, 2017, two of three consecutive testing events. These failures resulted in the laboratory's initial unsuccessful proficiency testing performance. b) The above noted findings were confirmed by an AAB representative on 8/16/17 at 12:00 PM, during a telephone interview. 2. A review of AAB proficiency testing evaluations on 8/14/18 revealed the laboratory scored 0 % for HCT for Event #1 of 2018, in addition to the earlier failures; thus resulting in unsuccessful participation for three of five testing events. 3. In a telephone interview on 8/15/18 at 11:05 AM, the testing personnel confirmed the laboratory failed to timely submit the data to AAB for grading for Event #1, 2018, resulting in zero percents scores for all analytes. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the CASPER reports (#153/#155), a review of American -- 4 of 5 -- Association of Bioanalysts (AAB) performance evaluations for Hematology, and a telephone interview with the laboratory personnel, the surveyor determined the laboratory director failed to ensure the laboratory submitted proficiency testing results of Hematology testing, Event #1, 2018, to the provider within the established timeframe for grading. This failure to submit the results within the established timeframe resulted in a failure to participate (zero percent scores). The findings include: 1. Refer to D2127. Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor -- 5 of 5 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --