Town Park Cmc Laboratory

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 11, 2025. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 review of the CASPER 155 report and review of the College of American Pathologists (CAP) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Blood Gas PCO2 in 2024 event 3 and 2025 event 1, resulting in an initial unsuccessful participation for Blood Gas PCO2 . Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of CAP PT reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 3rd event of 2024 and 1st event of 2025), resulting in an initial unsuccessful participation for Blood Gas PCO2. Findings: 1. A review of Casper Report 155 revealed the laboratory failed PCO2 on the following: 2024 Event 3 PCO2 Score 60% 2025 Event 1 PCO2 Score 60% 2. A review of the laboratory's CAP Reports confirmed the laboratory failed PCO2 with the aforementioned scores. 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 review of the CMS CASPER 155 report and review of CAP PT reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 review of the CMS CASPER Report 155 and the CAP 2024 event 3 and 2025 event 1 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in Blood Gas PCO2 in two consecutive testing events (2024 event 3 and 2025 event 1), resulting in the initial unsuccessful participation for PCO2. Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on June 29, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 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 observation during the lab tour and staff interview, the laboratory failed to ensure reagents, tubes, and test kits were stored in proper conditions by monitoring the environmental specifications by the manufacturers. Findings include: 1. Observation during the laboratory tour on 6/29/2022 at approximately 10:20 a.m. revealed the room temperature or humidity of the storeage room were not monitored to ensure proper storage conditions. 2. Interview with the laboratory technical supervisor (CMS 209) in the laboratory on 6/29/2022 at approximately 10:20 a.m. confirmed the room temperature or humidity of the storeage room were not monitored to ensure proper storage conditions. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) 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 -- The laboratory director must ensure that 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 Sysmex XN 10 installation data and staff interview, the laboratory director (LD) failed to approve the method comparison, carryover study, and reportable range verification performed on November 4, 2020. Findings include: 1. Review of the Sysmex XN 10 installation data including the method comparison, carryover verification, and reportable range verification revealed the LD did not approve the data before the XN 10 was used to report patient results. 2. Interview with the technical supervisor (CMS 209) on 6/29/22 at approximately 1:30 p.m in his office, verified the LD failed to approve the aforementioned installation data. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of Blood Bank Quality Controls (QC) records, procedure manual (SOP) and an interview with the laboratory technical supervisor, the laboratory director failed to provide overall Quality Assurance (QA) management and direction of the laboratory as required. Findings include: 1. Review of Blood Bank Quality Control (QC) records revealed the Blood Bank (QC) was not reviewed for July, August, September, November, or December 2021 by the Technical Supervisor (TS) or by the Laboratory Director. 2. Interview with the laboratory Technical Supervisor, at approximately 1:30 pm, on 6/29/2022 in the TS office, confirmed Blood Bank (QC) was not reviewed by the Technical Supervisor (TS) or Laboratory Director for the aforementioned dates. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of testing personnel documents and staff interview, the Technical Supervisor (TS) failed to perform annual competency on all testing personnel. Findings include: 1. Review of testing personnel training and competency documents revealed the TS failed to perform competency evaluations on 7 of 8 testing personnel (CMS 209) for the year of 2020. Documents were not available to review on staff # 1, 2, 3, 4, 5, 7, and 9 (CMS 209) for 2020. 2. Review of testing personnel training and competency documents revealed the TS failed to perform competency evaluations on -- 2 of 3 -- 2 of 8 testing personnel (CMS 209) for the year of 2021. Documents were not available to review on staff # 3 and 7 (CMS 209) for 2021. 3. Interview with the TS (CMS 209) in his office on 6/29/22 at 1245 p.m confirmed the aforemention statements. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 and 2 of 2020), resulting in the first 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 -- unsuccessful occurrence for Theophylline analyte #0735 in the specialty of Toxicology. Findings include: Refer to D2118 D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Theophylline analyte #0735 in the specialty of Toxicology. 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Theophylline #0735, on Events 1 and 2 of 2020 with a score of 0% for both events. 2. The criteria for acceptable performance for the specialty of Toxicology is 80%. 3. Desk review of the laboratory's proficiency testing reports from the College of American Pathology (CAP) confirmed the laboratory failed analyte #0735 Theophylline for Events 1 and 2 of 2020 resulting in the first unsuccessful performance. 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 an in-office desk review of proficiency testing (PT) records, the Laboratory Director failed to ensure the laboratory successfully participated in two out of three proficiency testing events (Events 1 and 2 of 2020) for analyte #0735 Theophylline in the specialty of Toxicology. Findings include: 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 an in-office desk review of proficiency testing (PT) records, the Laboratory Director failed to ensure the laboratory successfully participated in two out of three -- 2 of 3 -- proficiency testing events (Events 1 and 2 of 2020) for analyte #0735 Theophylline in the specialty of Toxicology. Findings include: Refer to D6016 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 07, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of Blood Bank maintenance and Quality Controls (QC) records, procedure manual (SOP) and an interview with the laboratory coordinator, the laboratory director failed to provide overall Quality Assurance (QA) management and direction of the laboratory as required. Findings include: Refer to D6093, D6094 D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of Blood Bank Quality Controls (QC) records, procedure manual (SOP) and an interview with the laboratory coordinator, the laboratory director failed to provide overall Quality Assurance (QA) management and direction of 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 as required. Findings include: 1.) A review of Blood Bank Quality Control (QC) records revealed that Blood Bank (QC) was not reviewed in 2018 and 2019 by the Technical Supervisor (TS) or laboratory director. 2.) An interview with the laboratory coordinator at approximately 01:55 pm on 01/07/2020 in the 2nd floor conference room confirmed Blood Bank (QC) was not reviewed by the Technical Supervisor (TS) or laboratory director for two years as part of overall (QA) in 2018 and 2019. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of Blood Bank Quality Controls (QC) records, procedure manual (SOP) and an interview with the laboratory coordinator, the laboratory director failed to provide overall Quality Assurance management and direction of the laboratory as required. Findings include: 1.) Blood Bank maintenance records review revealed the followings: freezer, refrigerator and incubator temperature logs were not reviewed for accuracy by the Technical Supervisor (TS) or laboratory director from September 2018 to December 2018. 2.) An interview with the laboratory coordinator at approximately 01:45 pm on 01/07/2020 in the 2nd floor conference room, confirmed the aformentioned Blood bank temperature logs were not reviewed by the (TS) or laboratory director as part of overall Quality Assurance (QA) from September to December 2018. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on October 9, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) report, the laboratory failed to maintain satisfactory performance in event 2 of 2018 resulting in the first 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 -- unsuccessful occurrence for ABO blood group, analyte # 865. Findings include: Refer to D 2153 D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) report, the laboratory failed to maintain satisfactory performance in event 2 of 2018 resulting in the first unsuccessful occurrence for ABO blood group, analyte # 865. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #865 ABO on event 2 of 2018 with a score of 80%. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed ABO analyte # 865 on event 2 of 2018. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) report, the laboratory director failed to ensure the laboratory maintained satisfactory performance in event 2 of 2018 resulting in the first unsuccessful occurrence for ABO blood group analyte # 865. Refer to D 6016 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) report, the laboratory -- 2 of 3 -- director failed to ensure the laboratory maintained satisfactory performance in event 2 of 2018 resulting in the first unsuccessful occurrence for ABO blood group analyte # 865. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #865 ABO on event 2 of 2018 with a score of 80%. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed ABO analyte # 865 on event 2 of 2018. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on April 30, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the College of American Pathologist (CAP), the laboratory failed to maintain satisfactory performance in two consecutive events (3rd 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 -- event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for fibrinogen, analyte # 825. Findings include: Refer to D 2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the College of American Pathologist (CAP), the laboratory failed to maintain satisfactory performance in two consecutive events (3rd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for fibrinogen, analyte # 825. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #825, fibrinogen, on event 3 of 2017 with a score of 0% and event 1 of 2018 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from CAP confirmed the laboratory failed fibrinogen on event 3 of 2017 and event 1 of 2018 resulting in the first unsuccessful performance. -- 2 of 2 --