Allison H Henderson Md Pa

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D5400 - 42 C.F.R. 493.1421 Condition: Analytic Systems D6000 - 42 C.F.R. 493.1421 Condition: Laboratory Manager D6033 - 42 C.F.R. 493.1421 Condition: Technical Consultant D6063 - 42 C.F.R. 493.1421 Condition: Testing Personnel Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records, American Association of Bioanalysts (AAB) Proficiency Testing (PT) records (2019) and staff interview, the laboratory director and testing person failed to attest to the routine integration of proficiency samples into the patient workload for 1 of 3 Hematology events in 2019. Findings Included: 1. Review of laboratory records revealed the laboratory tested hematology samples on the Sysmex pocHi-100i (Serial Number: G5131) for the following analytes which were included in the American Association of Bioanalysts Proficiency Testing: Leukocytes; Erythrocytes; Hemoglobin; Hematocrit; Platelets; Lymphocytes; Monocytes 2. Review of the "AAB Proficiency Testing Service 2019" attestation form, revealed the following statement: "Attestations The undersigned analyst attests that samples were tested in the same manner as patient samples." Further review revealed the proficiency testing analyst and laboratory director failed to attest to the routine integration of proficiency samples into the patient workload for 1 of 3 events 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 -- in 2019. 3. In an interview with the laboratory representative at 10:28 AM on 7/1/21, in the exam room, the representative was asked to provide documentation of the testing person and laboratory director attesting to the routine integration of PT samples into the patient workload. No documentation was provided. This confirmed the above findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of Sysmex pocHi-100i operator's manual and confirmed in staff interview, the laboratory failed to document performance of maintenance for the Sysmex pocHi-100i hematology analyzer for 52 of 52 weeks in 2019 and 2020, and 26 of 26 weeks in 2021. Findings Included: 1. Review of Sysmex pocHi-100i operator's manual stated the following maintenance requirements prior to patient sample analysis: "4 Maintenance.. 4.1.3 Shutdown- Daily.. 4.1.4 Clean Transducer- Every 2 weeks or 150 samples.. 4.1.5 Clean waste chamber- Every 3 months or 1500 samples.." The laboratory failed to provide documentation of performing maintenance on the Sysmex pocHi-100i hematology analyzer (Serial Number: G5131). 2. In an interview with the laboratory representative at 10:48 AM on 7/1/21, in the exam room, the representative was asked to provide documentation of maintenance performance for the Sysmex pocHi-100i hematology analyzer. The representative stated the laboratory performed all required maintenance but could provide no documentation of performing maintenance on the Sysmex pocHi-100i for 52 of 52 weeks in 2019 and 2020, and 26 of 26 weeks in 2021. This confirmed the above findings. -- 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 AAB (American Association of Bioanalysts) proficiency testing results and interview with the Office Manager the laboratory failed to score at least 80% for Leucocytes for 2 (1st and 2nd testing event out of 2018) out of 4 testing events (1st, 2nd, 3rd testing event in 2018 and 3rd testing event in 2017) reviewed (See D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 AAB (American Association of Bioanalysts) proficiency testing results and interview with the Office Manager the laboratory failed to score at least 80% for Leucocytes for 2 (1st and 2nd testing event out of 2018) out of 4 testing events (1st, 2nd, 3rd testing event in 2018 and 3rd testing event in 2017) reviewed. Findings Included: Review of AAB proficiency testing results revealed a 0% for Leukocytes in the 1st and 2nd testing event in 2018. During an interview on 11/08/18 at 2:00 PM the Office Manager confirmed the failures. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager the laboratory failed to perform competency evaluations on 3 out of 3 Testing Personnel. Findings Included: Review of the CMS 209 the laboratory has 3 Testing Personnel. Review of the Testing Personnel files revealed no competency evaluations. During an interview on 11/08/18 at 1:30 PM the Office Manager confirmed that there had been no competency evaluations performed on the 3 Testing Personnel. 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 record review and interview with the Office Manager the laboratory failed to document the humidity of the room where testing was performed since 08/11/17. Findings Included: Review of the manufacturers instructions for the Complete Blood Count (CBC) analyzer revealed that the humidity should be between 30%-85%. Review of daily logs revealed that the humidity of the room where testing was performed was not documented. During an interview on 11/08/18 at 3:00 PM the Office Manager confirmed that the laboratory did not document the room humidity. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) -- 2 of 3 -- (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview with the Office manager the laboratory failed to follow their policy to document Quality Assurance (QA) monthly for 1 out of 1 year (2017-2018) reviewed. Findings Included: Review of policies dated 08/11/17 by the Laboratory Director, the laboratory was to document QA monthly. No documentation of monthly QA was provided. During an interview on 11/08/18 at 2:00 PM the Office Manager confirmed that there was no monthly QA documented. 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 AAB (American Association of Bioanalysts) proficiency testing results and interview with the Office Manager the Laboratory Director failed to ensure the laboratory scored at least 80% for Leucocytes for 2 (1st and 2nd testing event out of 2018) out of 4 testing events (1st, 2nd, 3rd testing event in 2018 and 3rd testing event in 2017) reviewed (See 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 review of AAB (American Association of Bioanalysts) proficiency testing results and interview with the Office Manager the Laboratory Director failed to ensure the laboratory scored at least 80% for Leucocytes for 2 (1st and 2nd testing event out of 2018) out of 4 testing events (1st, 2nd, 3rd testing event in 2018 and 3rd testing event in 2017) reviewed. Findings Included: Review of AAB proficiency testing results revealed a 0% for Leukocytes in the 1st and 2nd testing event in 2018. During an interview on 11/08/18 at 2:00 PM the Office Manager confirmed the failures. -- 3 of 3 --