Albert G Kerr Md

Summary Statement of Deficiencies D0000 A recertification survey was performed October 31, 2022 at Albert Kerr MD, CLIA ID # 19D0710641. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include a policy stating written, detailed instructions for the reporting of SARS CoV-2 test results to the state public health agency, to include but not limited to who is responsible for reporting test results and the frequency at which reporting is performed. 2. In interview on October 31, 2022 at 03:00 pm, the Laboratory Director confirmed the laboratory did not include the above identified policy. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper 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 -- use. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer instructions, and interview with personnel, the laboratory failed to label hematology controls with updated expiration dates after opening. Findings: 1. Observation by surveyor during the laboratory tour on October 31, 2022 at 1:20 pm revealed the laboratory stored open Coulter 4C-ES Cell Control for Hematology testing (Lot Number: Low 068800, Normal 078800, High 088800; Expiration date 01/02/2023) in a refrigerator without labeling with the "open" and updated "expiration" dates. 2. Review of the Coulter 4C- ES Cell Control manufacturer's instructions under the "Storage, Stability, and Disposal" section revealed "For opened vial stability, refer to the Table of Expected Results for your system. Open vial stability 35 days". 3. In interview on October 31, 2022 at 2:40 pm, the Laboratory Director confirmed the laboratory did not label the in- use hematology control vials with "open" and "expiration" dates. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's instructions, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5415. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedure manual and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5401. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A PT Desk Review SURVEY was performed on February 11, 2019. Albert G Kerr - 19D0710641 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.807 CONDITION: Reinstatement of Nonwaived Testing 42 CFR 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 review of proficiency testing results from the CMS-153, CMS-155D and American Proficiency Institute (API), the laboratory failed to successfully participate 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 -- in proficiency testing as evidence by: 1. The laboratory failed to achieve satisfactory performance for Red Blood Cells (RBC) in three of four consecutive events resulting in non-initial unsuccessful participation. Refer to D2017 2. The laboratory failed to achieve a score of at least 80% for for Hematology analytes in three of four consecutive events. Refer to D2130. 3. The laboratory failed to acieve an overall score of at least 80% for two of three events in the specialty of Hematology. Refer to D2131 D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on review of proficiency testing results from the CMS-153, CMS-155D and American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Red Blood Cells (RBC) in three of four consecutive events resulting in non-initial unsuccessful participation. See 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 proficiency testing results from the CMS-155D and American Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for Hematology analytes in three of four consecutive events. Findings: 1. Review of proficiency testing records and the CMS 155D Report revealed the following proficiency testing scores for Red Blood Cells (RBC) resulting in non-initial unsuccessful performance: a. 2017 Event 3: Score of 60% for RBC b. 2018 Event 2: Score of 0% for RBC c. 2018 Event 3: Score of 0% for RBC 2. Review of proficiency testing records and the CMS 155D Report revealed the following proficiency testing scores for Hematocrit ()Hct) resulting in initial unsuccessful performance: a. 2018 Event 2: Score of 20% for Hct b. 2018 Event 3: Score of 40% for Hct D2131 HEMATOLOGY CFR(s): 493.851(g) -- 2 of 3 -- 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 review of proficiency testing records and CMS Report 0155D, the laboratory failed to acieve an overall score of at least 80% for two of three events in the specialty of Hematology. Findings: 1. Review of proficiency testing records and Casper Report 0155D revealed the laboratory did not score at least 80% for the following two out of three events in Hematolgy: a. 2018 Event 2: Score of 70% b. 2018 Event 3: Score of 73% 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. 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: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to achieve satisfactory performance for Red Blood Cells (RBC) in three of four consecutive events resulting in non-initial unsuccessful participation. Refer to D2017 2. The laboratory failed to achieve a score of at least 80% for for Hematology analytes in three of four consecutive events. Refer to D2130. 3. The laboratory failed to acieve an overall score of at least 80% for two of three events in the specialty of Hematology. Refer to D2131 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A PT Desk Review SURVEY was performed on October 5, 2018. Albert G Kerr - 19D0710641 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 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 review of proficiency testing results from the CMS-153, CMS-155D and American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing as evidence by: 1. The laboratory failed to attain a score of at 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 -- least 80% for Red Blood Cell and Hematocrit. Please refer to D2121. 2. The laboratory failed to attain an overall satisfactory score of at least 80% for Hematology in Event 2 of 2018. 3. The laboratory failed to achieve satisfactory performance for Hematocrit in two of three consecutive events resulting in initial unsuccessful participation. See D2130 D2121 HEMATOLOGY CFR(s): 493.851(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 review of the CMS 155D Report and American Proficiency Institute (API), the laboratory failed to attain a score of at least 80% for Red Blood Cell and Hematocrit. Findings: 1. Review of API Proficiency Testing Records revealed that the laboratory failed to achieve a score of at least 80% for the specialty of Hematology for the following events: For the 2nd Event in 2018 the laboratory received a score of 0% for Red Blood Cell (RBC). For the 3rd Event in 2017 the laboratory received a score of 60% for Red Blood Cell (RBC). For the 2nd Event in 2018 the laboratory received a score of 20% for Hematocrit (HCT). 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 proficiency testing results, the laboratory failed to attain a satisfactory score score of at least 80% for Hematology in Event 2 of 2018. Findings are: 1. Review of CASPER Reports 0155D and 0153D along with API Proficiency Testing Records revealed the laboratory received an overall score of 70 % for Hematology in the second event of 2018. 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 proficiency testing results from the CMS-155D and American Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for Red Blood Cells in two of three consecutive events. Findings: 1. Review of proficiency testing records and the CMS 155D Report revealed the following proficiency testing scores for Red Blood Cell (RBC) resulting in initial unsuccessful performance: a. 2018 Event 2: Score of 0% b. 2017 Event 3: Score of 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 2 of 3 -- 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. 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: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to attain a score of at least 80% for Red Blood Cell and Hematocrit. Please refer to D2121. 2. The laboratory failed to attain an overall satisfactory score of at least 80% for Hematology in Event 2 of 2018. 3. The laboratory failed to achieve satisfactory performance for Hematocrit in two of three consecutive events resulting in initial unsuccessful participation. See D2130 -- 3 of 3 --