Hoover Family Medicine

Summary Statement of Deficiencies D0000 D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the Policies and Procedures manual and an interview with the Technical Consultant (TC), the Laboratory Director failed to establish and maintain a Quality Assessment program to assure the quality of laboratory services provided. This was noted from the date of the last survey, 12-202022 to the date of the current survey, 12-19-2024. The findings include: 1. A review of Policies and Procedures manual revealed a lack of a Quality Assessment program implemented to monitor and evaluate the laboratory's ability to perform quality testing and provide remedial action when failures are identified. 2. The TC confirmed the above findings during the exit conference on 12-19-2024 at 1:00 PM. 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 test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Technical Consultant(TC), the TC failed to ensure three of the three Testing Personnel (TP) listed on the CMS-209 (Laboratory Personnel Report) had competency assessments which included the six minimal regulatory requirements. The surveyor noted six of the six requirements were missing on annual and semi-annual competencies. The findings include: 1. A review of the 2022 through 2024 personnel records revealed the TP competency assessment for Hematology specialty had no documentation of six of the six minimal regulatory requirements. The surveyor noted the missing six requirements were as follows: (1) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing, (2) Monitoring the recording and reporting of test results, (3) Review of intermediate test results of worksheets, quality control records, proficiency testing results, and preventive maintenance results. (4) Direct observation of performance of instrument maintenance and function checks. (5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. (6) Assessment of problem solving skills. 2. The TC confirmed the above findings during the exit conference on 12/19 /2024 at 1:00 PM. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Technical Consultant (TC), the TC failed to ensure all Testing Personnel (TP) listed on the CMS- 209 (Laboratory Personnel Report) who performed moderate complexity testing had semi-annual competency assessments. The surveyor noted three of the three TP had no documentation of semi-annual competency assessment. The findings include: 1. A review of the personnel records revealed three of the three TP who performed Hematology testing did not have documentation of the semi-annual competency assessment. 2. The TC confirmed the above findings during the exit conference on 12 /19/2024 at 1:00 PM, 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 a review of the personnel records and an interview with the Technical Consultant (TC), the TC failed to ensure all Testing Personnel (TP) listed on the CMS- 209 (Laboratory Personnel Report) who performed moderate complexity testing had annual competency assessments. The surveyor noted three of the three TP had no -- 2 of 3 -- documentation of annual competency assessment. The findings include: 1. A review of the personnel records revealed the TP who performed Hematology testing did not have annual competency assessment for 2022-2024. 2. The TC confirmed the above findings during the exit conference on 12/19/2024 at 1:00 PM, -- 3 of 3 --

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 a review of the test menu on tour with the testing personnel, a review of American Proficiency Institute (API) proficiency testing records, a review of the patient test log, and an interview with the testing personnel and technical consultant, the surveyor determined the laboratory failed to enroll in proficiency testing for serum hcg (human chorionic gonadotropin) testing in 2018 - 2020 (the survey review period). The findings include: 1. During the initial tour of the laboratory on 11/23 /2020 at 10:15 AM, the testing personnel stated serum hcg testing was performed using the Dectector hcg Combi Kit. The surveyor observed the combi kit on the shelf and asked the testing personnel again if serum was used to perform the testing. The testing personnel again stated serum and urine specimens were used to perform the testing with the kit observed. 2. The API proficiency testing records did not include any testing of serum hcg specimens. 3. A review of the type-written patient test log revealed from 2/14/2019 - 9/06/2019, seven (7) patient serum hcg tests were performed; and from 1/08/2020 - 7/08/2020, ten (10) patient serum hcg tests were performed. 4. During an interview on 11/23/2020 at 1:05 PM, the surveyor asked the testing personnel again if patient tests had been performed using serum samples with the hcg combi kit. The testing personnel stated a handful of tests had been done, all in 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 -- 2019, and none in 2020. The surveyor asked the testing personnel to review the patient test log. The testing personnel reviewed the log and confirmed serum hcg patient testing was also performed in 2020. 5. During the exit interview on 11/23 /2020, beginning at 1:10 PM, the surveyor asked the testing personnel about the enrollment in proficiency testing for serum hcg testing. The testing personnel stated the laboratory was not enrolled in proficiency testing for hcg tests, only for CBC (Complete Blood Count) testing. At 1:44 PM, the Technical Consultant stated serum hcg testing was send-out testing. The testing personnel stated the laboratory staff had performed the testing in-house on serum samples. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the calibration records for the Beckman Coulter Act Diff 2, a review of the manufacturer's instructions, and an interview with the testing personnel, it was determined the laboratory failed to calibrate the instrument every six months, as stated was the usual policy; and further failed to run the quality control following a calibration to verify the accuracy of the calibration. This affected the survey review period from July 2018 to current survey date (11/23/2020). The findings include: 1. A review of the calibration records for the Act Diff 2 revealed documentation of calibration performed on 3/22/2019, ten months after the calibration performed on 5 /2018 (reviewed on the previous survey 6/12/2018). The next calibrations were performed on 9/11/2019 and 9/17/2019 and then 11/19/2020, exceeding one year. The calibration performed on 3/22/19 after 1:00 PM failed to include quality control testing after the calibration to verify the accuracy. 2. A review of the manufacturer's instruction revealed: "...17. Verify calibration by running 4C Plus cell control..." The laboratory's policy and procedure only outlined the procedure how to perform a calibration, but failed to include the frequency or when to calibrate. 3. During an interview on 11/23/2020 at 1:10 PM, the testing personnel stated the Act Diff is calibrated when "anything" is off, and usually every six months. The surveyor asked the personnel to review the policy and procedure and explain when the calibrations were to be performed. The testing personnel stated the procedure outlines how to do the calibration, but not why or the frequency. The testing personnel confirmed the more than one year lapse between 9/17/2019 and 11/19/2020, stating the laboratory was closed for a time during the pandemic (March 27 - May 11), and the calibration was not done when the laboratory reopened, May 11, 2020. When asked in quality control should be run after a calibration, the testing personnel answered, "Yes." The surveyor asked the personnel to review the calibration record, dated 3/22/19, for quality control testing. The testing personnel confirmed the quality controls were not run after the calibration, but could not explain why. -- 2 of 3 -- D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the test menu on tour with the testing personnel, a review of the patient test log, a lack of documentation of quality control testing, and an interview with the testing personnel, the surveyor determined the laboratory failed to perform external quality control testing for serum hcg (human choriuonic gonadotropin) testing in 2018 - 2020 (the survey review period). The findings include: 1. During the initial tour of the laboratory on 11/23/2020 at 10:15 AM, the testing personnel stated serum hcg testing was performed using the Detector hcg Combi Kit. The surveyor observed the combi kit on the shelf and asked the testing personnel again if serum was used to perform the testing. The testing personnel again stated serum and urine specimens were used to perform the testing with the kit observed. The surveyor asked how often controls were run, and the testing personnel stated the controls were run "sporadically." After further discussion, the surveyor concluded the testing personnel was confusing external quality control testing with proficiency testing. 2. During an interview on 11/23/2020 at 1:05 PM, the surveyor asked the testing personnel if any external controls were run with the hcg combi kit. The testing personnel stated other than the internal quality control, no other quality control was run, nor was there an IQCP (Individualized Quality Control Plan). The testing personnel stated the problem will be corrected in the future, by not using a serum sample to perform the tests. 3. A review of the type-written patient test log for preganancy serum tests revealed at the top of the log, "NO CONTROL TO TEST." From 2/14/2019 - 9/06/2019, seven (7) patient serum hcg tests were performed; and from 1/08/2020 - 7/08/2020, ten (10) patient serum hcg tests were performed. At 1:07 PM, the testing personnel reviewed the patient test log and confirmed the patient testing was performed in-house. -- 3 of 3 --

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 API (American Proficiency Institute) proficiency testing evaluations and the CASPER reports (#153/#155), the surveyor determined the laboratory failed to successfully participate in proficiency testing for Hemoglobin (Hgb) for two of three consecutive testing events, Event #1 and #3 of 2018. These failures resulted in the laboratory's initial unsuccessful proficiency testing participation. The findings include: 1. A review of the API proficiency testing evaluations and CASPER reports revealed the laboratory scored sixty percent (60 %) 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 -- for Hgb for Event #1 and Event #3 of 2018, two of three consecutive testing events. 2. These failures resulted in the laboratory's initial unsuccessful proficiency testing participation. 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 a review of API (American Proficiency Institute) proficiency testing evaluations and the CASPER reports (#153/#155), the surveyor determined the laboratory failed to achieve satisfactory performance for Hemoglobin (Hgb) testing for two of three consecutive testing events, Events #1 and #3 of 2018. These failures resulted in the laboratory's initial unsuccessful participation. The findings include: 1. A review of the API proficiency testing evaluations and CASPER reports revealed the laboratory scored sixty percent (60 %) for Hgb for Event #1 and Event #3 of 2018, two of three consecutive testing events. 2. These failures resulted in the laboratory's initial unsuccessful proficiency testing participation. -- 2 of 2 --