Avalon Medical Clinic Llc

Summary Statement of Deficiencies 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 review of the Centers for Medicare and Medicaid Services (CMS) database system for proficiency testing CASPER report 0155D, laboratory records, and interview with testing personnel (TP#1)/Office Manager, the laboratory failed to enroll and participate in an HHS approved proficiency testing (PT) program for Hematology-CBC (Complete Blood Count) for two of two proficiency testing events for 2024. Findings Include: 1. Review of the CMS CASPER report for proficiency testing for the laboratory did not generate a report for any proficiency testing scores for 2024. 2. Review of laboratory records confirmed there was no documentation of enrollment or participation in an HHS approved proficiency testing program for Hematology for 2024. 3. The TP#1/Office Manager confirmed on 6/19/2024 at 2:00 p. m. that the laboratory was not enrolled in proficiency testing for CBC testing for two of two proficiency events in 2024. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish 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 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory personnel records and interview with testing personnel (TP) #1/Office Manager, the laboratory failed to establish and follow written policies to assess the technical consultant (TC) for one of one annual competencies. Findings include: 1. Review of the personnel records along with the 209 personnel form, revealed there was no annual competency/evaluation available for review. 2. Interview with the TP #1/Office Manager, confirmed on 6/19/2024 at 4:30 p.m. the technical consultant's competency had not been performed by the laboratory director since the TC was hired in December 2022. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, Centers for Medicare and Medicaid Services (CMS) database proficiency testing CASPER report 0155D and confirmation with testing personnel (TP)#1/Office Manager, the laboratory director failed to ensure the laboratory was enrolled in an HHS approved proficiency testing (PT) program for CBC (complete blood count) performed on the Sysmex XP 300 hematology analyzer for four of six testing events the year 2024. Findings include: 1. Review of the CMS database proficiency testing CASPER report revealed no scores or participation for CBC for the 1st and 2nd events of 2024. 2. Review of the laboratory proficiency records from 10/12/2022 through 6/19/2024, revealed no evidence of proficiency testing enrollment or participation for the 1st or 2nd events of 2024. 3. The TP#1/Office Manager confirmed in an interview on 6/19/2024 at 2:00 p. m. that the laboratory director did not ensure the laboratory was enrolled in proficiency testing for CBC for the the year 2024. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records, Centers of Medicare and Medicaid Services (CMS)testing report and interview with testing personnel (TP) #1/Office Manager, the technical consultant failed to ensure the laboratory enrolled -- 2 of 4 -- and participated in an HHS approved proficiency testing (PT) program for CBC (complete blood count) performed on the Sysmex XP 300 hematology analyzer for the 2nd and 3rd events of 2023 and enroll in 2024. Findings include: 1. Review of the laboratory proficiency records for 2022, 2023 and 2024, and the CMS database report revealed no proficiency testing was reported and the laboratory did not perform or participate in proficiency testing for CBC's for the 2nd and 3rd events of 2023 nor did the laboratory enroll and participate in the 1st and 2nd events of 2024. The laboratory did not participate in 4 of 6 proficiency events since the last survey 10/12/2022. 2. The TP#1/Office Manager confirmed in an interview on 6/19/2024 at 10:00 a.m that the laboratory did not participate in the 2nd and 3rd proficiency events of 2023 and 1st and 2nd events of 2024 for hematology testing (CBC). The laboratory was still performing and reporting patient CBC testing during this timeframe. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory testing records, policy and procedure manual and interview with the testing personnel (TP)#1/Office Manager, the technical consultant (TC) failed to document review of the Sysmex XP 300 calibration, quality controls, maintenance and temperature logs for 8 of 20 months. Findings Include: 1. Review of the laboratory policy and procedure manual revealed the Technical Consultant would visit the laboratory a minimum of quarterly per year. During those visits he/she would: a. Print and review the CBC daily quality control b. Review the maintenance logs the CBC instrument c. Review temperatures logs for room, refrigerator and freezer d. Review proficiency testing results e. Perform other technical consultant responsibilities as need. These duties/responsibilities had not been performed by the TC since 10/10/23 2. Review of laboratory records from 10/12/2022 through 6/19 /2024 revealed no documented review by the TC for the following records : a. Laboratory temperature logs (room, refrigerator, freezer, humidity). (8 of 20 months) b. Sysmex XP 300 calibration on 11/2/23 c. Sysmex XP 300 quality controls. (8 of 20 months) d. Sysmex XP 300 maintenance (daily, weekly, monthly, quarterly). (8 of 20 months) 3. Interview with TP #1/Office Manager on 6/19/2024 at 4:30 p.m. confirmed there was no available documentation of review of these records by the technical consultant after 10/10/2023. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory personnel competency evaluations, and interview with TP#1/Office Manager, the technical consultant failed -- 3 of 4 -- to evaluate the performance for testing personnel, (TP) #1 listed on the CMS 209 form, at least annually for the year 2023. Findings include: 1. The surveyor reviewed personnel records form 10/12/2022 through 6/19/2024 including competency evaluations and the CMS 209 personnel form. 2. There was no annual competency evaluation for TP#1 performed by the TC for 2023. 3. The initial training for TP#1 was completed on 12/6/2022. The 6 month evaluation was performed on 7/14/2023 and the first annual competency was due in 12/2023. 4. The TP#1/Office Manager confirmed in an interview on 6/19/2024 at 4:30 p.m. that no annual competency evaluation had been documented as performed by the TC for TP#1. (1 of 1 annual competency evaluation was not performed). -- 4 of 4 --

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS (Centers for Medicare and Medicaid Services) 209 personnel form, lack of qualifying documentation, and interview with testing personnel (TP) #2/office manager at 2:30 p.m. on 1/12/2022, the laboratory did not have a technical consultant who meets the qualification requirements of 493.1411 of this subpart. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical 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 -- oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form, lack of qualifying documentation available for review and interview with the TP #2/office manager at 2:30 p.m. on 10 /12/2022, the laboratory did not have an individual designated as technical consultant who meets the qualification requirements of 493.1411 of this subpart from 3/1/2022 through 10/12/2022. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory testing records from 1/3/2022 through 10/12/2022 and interview with TP #2/office manager at 3:30 p.m. on 10/12/2022, the following records had not been documented as reviewed by a qualified technical consultant (TC): Findings Include: 1. Surveyor review of temperature records, quality control reports, proficiency testing reports, and Sysmex XP-300 calibration records from 1/3 /2022 through 10/12/2022 revealed the following records had not been documented as reviewed by a qualified technical consultant: a. Temperature logs (room, freezer, humidity, and refrigerator) from 1/11/2022 through 10/12/2022 b. Sysmex XP-300 quality control (QC) from 1/11/22 through 10/12/22 c. Proficiency Testing results for the 1st and 2nd events of 2022 d. Sysmex XP-300 calibration documents for 12/3 /2021 (installation) and 6/23/2022 2. Interview with TP #2/Office manager at 3:30 p. m. on 10/12/2022 confirmed there was no documented review of these records by a qualified TC. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) -- 2 of 3 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of testing personnel records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with TP #2 /office manager at 4:00 p.m. on 10/12/2022, a qualified technical consultant failed to evaluate semiannually and document the performance of TP #1, #2 and #3 who are responsible for performing moderate laboratory testing. Findings include: 1. The surveyor reviewed laboratory personnel records including the CMS 209 form available on 10/12/22. TP #1 training date 12/23/2021 - no 6 month competency evaluation which was due in June 2022 TP #2 training date 2/8/2022 - no 6 month competency evaluation which was due in August 2022 TP #3 training date 2/8/2022 - no 6 month competency evaluation which was due in August 2022 2. Interview with TP #2/office manager confirmed at 4:00 p.m. that TP #1, TP #2 and TP #3 had no documented 6 month competency evaluations by a qualified TC during their first year of moderate complexity testing. -- 3 of 3 --