Heritage Medical Associates Pc

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 Heritage Medical Associates laboratory notification form and American Proficiency Testing (API) performance summary reports, the laboratory failed to successfully participate in Bacteriology in Urine Identification in the 1st and 2nd event 2019 and 1st event 2020 resulting in the second unsuccessful PT performance occurrence. (Refer to D2028). D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- 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 Heritage Medical Associates laboratory notification form and American Proficiency Testing (API) performance summary reports, the laboratory failed to successfully participate in Bacteriology in Urine Identification in the 1st and 2nd event 2019 and 1st event 2020 resulting in the second unsuccessful PT performance occurrence. The findings include: 1. Review of the laboratory notification form revealed a score of 25% in the 2nd event 2019 and a score of 75% for the 1st event 2020. 2. Review of the API evaluation report revealed a score of 0% for the 1st event 2019, score of 25% for the 2nd event 2019 and a score of 75% for the 1st event 2020. -- 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 Review of the Centers for Medicare and Medicaid Service (CMS) CASPER report 155 and the American Proficiency Institute (API) Performance Summary report the laboratory failed to achieve successful performance for the1st and 2nd event 2019 in the sub-specialty Bacteriology for Urine Colony Count and Urine Identification resulting in 1st unsuccessful performance in 2019. (Refer to D2028) D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 -- 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: This STANDARD is not met as evidenced by: 1. Review of the CMS Casper 155 report for the sub-specialty Bacteriology revealed a score of 71% in the 1st event and a score of 79% in the 2nd event of 2019. 2. Review of the API performance summary for the analyte Urine Colony Count with a score of 50% for the 1st and 2nd event of 2019, resulting in an overall score of 71% for the sub-specialty of Bacteriology. 3. Review of the API performance summary for the analyte Urine Identification with a score of 0% for the 1st event and a score of 25% for the 2nd event of 2019, resulting in an overall score of 79% for the sub-specialty of Bacteriology. -- 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 Review of the Centers for Medicare and Medicaide Service (CMS) CASPER report 155 and the American Proficiency Institute (API) Performance Summary report the laboratory failed to achieve successful performance for the 3rd event 2018 and 1st event 2019 for the specialty Bacteriology with a score of 70% in the analyte Potassium Hydroxide (KOH) resulting in the first unsuccessful performance in 2019. (Refer to D2038) D2038 MYCOLOGY CFR(s): 493.827(a) 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 -- 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 review of the American Proficiency Institute (API) Performance Summary report and interview with the lead testing person the laboratory failed to attain an overall socre of at least 80% in the subspecialty Mycology in the 3rd event 2018 with a score of 50% and 1st event 2019 with a score of 50% in the analyte Potassium Hydroxide (KOH) resulting with a score of 70%. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institutes (API) records and interview with the lead testing person the laboratory failed to retain signed attestation statements and API performance summary evaluation sheets in 2018. 1. Review of API records revealed the laboratory failed to retain signed attestation statements for 1st event Microbiology, and 2nd event Immunology, and missing API performance summary evaluation sheets for 1st and 2nd event Chemistry, 2nd event Microbiology and 3rd event Coagulation in 2018. 2. Interview with the lead testing person on May 14, 2019 at 2:30 confirmed the laboratory failed to retain signed attestation statements for 1st event Microbiology, and 2nd event Immunology, and failed to retain API performance summary evaluation sheets for 1st and 2nd event Chemistry, 2nd event Microbiology and 3rd event Coagulation in 2018. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of Quality Assurance (QA) documents for review, and interview with the lead testing person the laboratory failed to conduct QA reviews for the general laboratory systems quality assessments from September 1, 2017 to May 14, 2019. 1. Lack of QA documents avaliable for review confirmed the laboratory had no QA records for reviews from September 1, 2017 to May 14, 2019. 2. Interview with the lead testing person on May 14, 2019 at 2:45 pm confirmed the laboratory failed to conduct QA reviews for the general laboratory systems quality assessments from September 1, 2017 to May 14, 2019. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) -- 2 of 4 -- 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 site observation of the 2nd floor laboratory and interview with the lead testing person the laboratory failed to ensure KOH and saline reagents have not exceeded their expiration date of January 1, 2018 for KOH and February 28, 2019 for Saline. The findings include: 1. During on site observation of the 2nd floor laboratory revealed the laboratory failed to ensure KOH and saline reagents have not exceeded their expiration date of January 1, 2018 for KOH and February 28, 2019 for Saline. 2. Interview with the lead testing person on May 14, 2019 at 2:30 confirmed the laboratory failed to ensure KOH and saline reagents have not exceeded their expiration date of January 1, 2018 for KOH and February 28, 2019 for Saline. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) records for Microbiology, Microbiology QC procedure and interview with the lead testing person the laboratory failed to 1) check each batch of media for sterility for Blood Agar Plates (BAP), MacConkey (MAC) media and Strep Select media and 2) failed to check each batch of BAP and MAC media for select or inhibit specific organisms for growth between September 2017 and May 14, 2019. The findings include: 1. Review of the Microbiology QC records revealed the laboratory failed to perform sterility checks for each batch/lot number of BAP, MAC and Strep select media between September 2017 and May 14, 2019. 2. Review of the Microbiology QC records revealed the laboratory failed to check each batch of BAP and MAC media for select or inhibit specific organisms for growth between September 2017 and May 14, 2019. 3. Review of the Microbiology QC procedure revealed the laboratory failed to follow the Microbiology QC procedure for sterility checks and select or inhibit specific organisms for growth for BAP and MAC media between September 2017 and May 14, 2019. 4. Interview with the lead testing person on May 14, 2019 at 2:30 pm confirmed the laboratory failed to 1) check each batch of media for sterility for BAP, MAC and Strep Select media and 2) failed to check each batch of BAP and MAC media for select or inhibit specific organisms for growth between September 2017 and May 14, 2019. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform -- 3 of 4 -- test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competencies and interview with the lead testing person the technical consultant failed to perform competency assessment on 3 out of 15 testing personnel listed on the Centers for Medicare and Medicaid Services (CMS) 209 in 2018. 1. Review of testing personnel competencies revealed the technical consultant failed to perform personnel competencies on testing persons 10- 12 listed on the CMS 209 in 2018. 2. Interview with the lead testing person on May 14, 2019 at 2:45 pm confirmed the technical consultant failed to perform personnel competencies on testing persons 10-12 listed on the CMS 209 in 2018. -- 4 of 4 --