American Samoa Dept Of Health Clinical Lab

Summary Statement of Deficiencies D0000 A federal surveyor from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted a recertification survey on 8/14/2025, the following standard level deficiencies were cited: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 direct observation, review of the manufacturer's instructions, and interview with testing personal #1, the laboratory failed to to define, monitor, and document room temperature where one hundred seventy-five Becton Dickinson (BD) tubes were stored in the phlebotomy area as evidenced by: 1. Based on direct observation at 1420 the laboratory had the following tubes in the phlebotomy room: a. 47- BD 3.5ml SST Lot #435605 expiration date:12-22-2025 b. 104- BD 3.0ml EDTA lot#434405 expiration date: 4-30-2026 c. 24- BD EDTA lot#5036670 expiration date: 6-30-2026 2. In review of the manufacturer's instruction labeled on the package for storage requirements stated, "4-25 degrees C." 3. In interview with testing person #1 at 1421 she stated that they do not monitor room temperature in the phlebotomy area. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 -- (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: Based on manufacturer's instructions, review of the laboratory's maintenance records, and interview with testing person #5, the laboratory failed to perform monthly and quarterly maintenance according to manufacturer's instructions for the Gene Xpert and Sysmex XP-300 for 8 of 8 months reviewed in 2025 as evidenced by: 1. In review of the manufacturer's instructions for the Gene Xpert under 9.1 Maintenance tasks, the following maintenance is due quarterly and monthly: a. Quarterly - Clean plunger rod and cartridge bay b. Quarterly - Clean the instrument surfaces c. Monthly - Archive tests d. Monthly - Purge tests e. Monthly - Replace fan filter 2. In review of the manufacturer's instruction for the Sysmex XP-300 under Cleaning and Maintenance, the following maintenance is due quarterly and monthly: a. Every 3 month - Clean SRV b. Monthly - Clean TD c. Monthly- Clean waste chamber 3. In review of the laboratory's maintenance log (January 2025 through the time of the survey) for Gene Expert the laboratory did not perform the monthly and quarterly maintenance. 4. In review of the laboratory's maintenance log (January 2025 through the time of the survey) for the XP-300 the laboratory did not perform quarterly and monthly maintenance 5. In interview with testing personnel #5 at 1322 she stated that they did not do the monthly or quarterly maintenance, and she didn't know why it hadn't been done. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: I. Based on review of the laboratory's individual quality control plan (IQCP) and interview with testing person #1, the laboratory failed to have a risk assessment (RA) for the Biofire GI panel/Respiratory Panel and no RA for the Gene Xpert (Tuberculosis[TB], Gonorrhea /Chylamdia [GC/CT] ) assays reviewed for 2024 and 2025 as evidenced by: 1. In review of the laboratory's IQCP the laboratory could not provide documentation for their risk assessments which did not include specimen, test system, reagent, environment, and testing personnel for both the Gene Xpert and Biofire. 2. In an interview with testing person #1 at 1130 she stated that they did not have the risk assessment for either one of the platforms. -- 2 of 3 -- D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control plan, quality control records, patient testing records, and interview with testing person #1, the laboratory failed to follow their quality control plan for running quality control once a month for 1 of 4 months in 2024 reviewed for the Gene Xpert Gonorrhea /Chylamdia [GC/CT] ) as evidenced by: 1. In review of the laboratory quality control plan for the Gene Xpert (GC/CT) they were to run the external controls once a month. 2. In review of the laboratory quality control records, for September 2024 to December 2024, the laboratory did not an external control for December 2024. 3. The following patients were ran without a monthly control: a. 12/27/2024 patient #193692 b. 12/27/2024 patient #10007835 c.12/27/2024 patient #197200 3. In an interview with testing person #1 at 1132, she stated the QC bottles expired on the 21st of November so they ran an extra external control on November 21st to cover those patient in all of December. -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the laboratory's standard operating procedure (SOP) for the Rapid Plasma Reagin (RPR) test, manufacturer's instructions, direct observation, and interview with testing personnel (TP) #6, the laboratory failed to perform the RPR tests following the manufacturer's instructions. The laboratory reports performing approximately 13 RPR tests annually. Findings: 1. The laboratory performs RPR tests using the Arlington Scientific RPR test kit which according to the manufacturer's instructions requires placing the test card on an automatic rotator and placing the cover to maintain humidity. 2. A review of the laboratory's SOP for the RPR testing states that the laboratory must place the test card on a rotator and cover it to maintain humidity. 3. Direct observation of the RPR testing area and mechanical rotator on August 24, 2023, at approximately 11:55 AM revealed that no rotator cover was present. 4. An interview with TP #6 on August 24, 2023, at approximately 2:10 PM confirmed that the laboratory was not utilizing the rotator cover when performing RPR testing. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish 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 -- maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory maintenance records, and interview with testing personnel (TP), it was determined that the laboratory failed to establish a maintenance protocol that ensures the performance of its Eppendorf pipettes used for Rapid Plasma Reagin (RPR) testing for accurate and reliable test results. The laboratory reports performing approximately 13 RPR tests annually. Findings: 1. Direct observation of three Eppendorf pipettes serial numbers P19546D, P48222H, and P47992H located in the RPR testing area on August 29, 2023, at approximately 11:55 AM revealed that no calibration sticker was present on the pipettes. 2. A review of the laboratory's maintenance records revealed that the laboratory did not perform calibrations for the three Eppendorf pipettes. 3. An interview with TP #1 on August 24, 2023, at approximately 11:55 AM confirmed that the laboratory failed to establish a maintenance protocol for the Eppendorf pipettes and did not perform calibrations to ensure accurate and reliable test results since the pipettes were acquired approximately in December of 2021. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of the laboratory's patient test reports and an interview with testing personnel (TP) #1, the laboratory failed to ensure that the test reports indicated the name and address of the laboratory location where the test was performed. The laboratory reported performing approximately 3,155 tests annually. Findings: 1. Upon review of patient test reports on August 24, 2023, nine of nine reports indicated the name and address of a different laboratory having performed the testing and not of the American Samoa Department of Health, Fatuna Family Health Center Laboratory. 2. An interview with TP#1 on August 24, 2023, at approximately 1:15 PM confirmed that the laboratory failed to have the correct name and address of the laboratory on its patient test reports. D6056 CLINICAL CONSULTANT CFR(s): 493.1415 The laboratory must have a clinical consultant who meets the qualification requirements of 493.1417 of this part and provides clinical consultation in accordance with 493.1419 of this part. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on a review of the laboratory's personnel records and an interview with the testing personnel (TP) #1, the laboratory failed to ensure the Clinical Consultant (CC) met the required educational qualifications. A review of personnel records and an interview with TP #1 revealed that the CC did not possess the academic credential evaluation required to qualify as CC. (Refer to D6057). D6057 CLINICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1417 The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. The clinical consultant must-- (a) Be qualified as a laboratory director under 493. 1405(b)(1), (2), or (3)(i); or (b) Be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located. This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and an interview with the testing personnel (TP) #1, the laboratory failed to ensure the Clinical Consultant (CC) met the required educational qualifications. Findings: 1. The laboratory could not provide foreign equivalency documentation performed by a nationally recognized organization to verify academic credentials for the CC. 2. An interview with TP#1 on August 24, 2023, at approximately 10:30 AM confirmed that the laboratory failed to have a qualified CC due to the lack of academic credential evaluation. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the laboratory's personnel records and an interview with testing personnel (TP) #1, the laboratory failed to ensure TP #3 met the required educational qualifications. A review of personnel records and an interview with TP #1 revealed that one of six TP did not have the proper academic credential evaluation required to perform moderate complexity testing (Refer to D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an -- 3 of 4 -- accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and an interview with testing personnel (TP) #1, the laboratory failed to ensure that one of six TP had the proper academic credential evaluation to qualify as TP performing moderate complexity testing. Findings: 1. The laboratory could not provide foreign equivalency documentation performed by a nationally recognized organization to verify academic credentials for TP #3. 2. An interview with TP #1 on August 24, 2023, at approximately 2:00 PM confirmed that TP #3 did not possess the required academic credential evaluation. -- 4 of 4 --

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 laboratory's testing menu and interview with the laboratory Manager, the laboratory failed to enroll in an approved proficiency testing (PT) program or programs for each of the specialties and subspecialties for which it seeks certification. Findings included: a. The laboratory was certified in 2017 for moderate complexity testing for the specialty/subspecialty of Microbiology/Mycobacteriology. b. The laboratory failed to enroll for PT for event 1 of 2018 for Mycobacteriology (MTB). c. Review of the laboratory testing menu on November 14, 2019, revealed the addition of subspecialty bacteriology (C. trachomatis, N.gonorrhoeae) testing on the GeneXpert analyzer. d. The laboratory had added the subspecialty to the tesing menu in 2019, but had failed to notify CMS of the addition of this subspecialty to the CLIA certificate, and designate to the PT organization API and CAP to report the results to CMS. e. Tour of the laboratory on November 14, 2019, revealed two Sysmex XP 300 automated hematology analyzers. By interview with the testing personnel and laboratory manager, the staff confirmed that the laboratory had initiated patient testing and release of patient results for complete blood counts (CBC), Hemaglobin (Hgb) and Hematocrit (HCT), on July 1, 2019. e. The laboratory validation records were completed and signed by the laboratory director in February of 2019, but the did not Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- have evidence of enrollment or performance of proficiency testing for automated CBC, or H&H for 2019. f. The laboratory testing personnel and laboratory manager confirmed by interview on November 14, 2019, at approximately 11:00 a.m., that the laboratory had not enrolled or performed proficiency testing for automated CBC, Hgb /Hct (H&H) for 2019, and for event (1) 2018 for MTB. g. The laboratory tested and released approximately (187) H&H, (77) CBC , and (100) patient results between July 1, 2019 to November 14, 2019. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on review of the CMS QIES CASPER 155D, the laboratory proficiency testing records and interview with the laboratory technical consultant on November 14, 2019, the laboratory failed to (1) notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart, and (2)(i) failed to designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS. The findings included: a. The laboratory was certified in 2017 for subspecialty of mycobacteriology (MTB) testing on the GeneXpert PCR moderate complexity testing. The laboratory had enrolled in with American Proficiency Institute (API) and College of American Pathologists (CAP) in 2018 for MTB and NG/CL PT in 2019 and 2019, but had neglected to ensure that the PT organizations were submitting data to HHS. b. Upon review of the CMS QIES CASPER 155D report, and the PT testing in the CMS- web 116, the laboratory still has not indicated to their PT organizations to transmit their PT results HHS. c. The laboratory technical supervisor confirmed by interview on November 14, 2019, that the laboratory failed to notify CMS of the addition of new testing specialties/subspecialties and the PT programs to which they would be enrolled. 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 the laboratory's proficiency testing records (PT), and interview with the laboraotry Technical Consultant (TC) on November 14, 2019, the laboratory director failed to document and attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. The Findings included: a. The laboratory is enrolled for proficiency testing with American Proficency Institure (API) and College of American Pathologists (CAP) for mycobacteriology and -- 2 of 7 -- bacteriology. b. The laboratory director failed to document the attestation signature forms of PT testing for proficiency testing provided by the API organization Event (2) and event (3) in 2019 and attestation form provided by CAP event (2) 2019. c. The laboratory manager confirmed the lack of laboratory director review by interview on November 14, 2019 at approximately 11:15 a.m. d. The laboratory performs approximately 500 moderate complexity patient tests annually. 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 review of the laboratory's CMS-209 testing personnel form, maintenance logs and interview with testing personnel on November 14, 2019, the laboratory failed as specified in the personnel requirements in subpart M, to establish and follow written policies and procedures to assess employees and, if applicable, consultant competency. The findings included: a. The laboratory's CMS-209 testing personnel form lists three testing personnel (TP-1), (TP-2), (TP-3). TP (1) and (2) both perform patient testing on the GeneXpert for mycobacterology and bacterology, as well as hematology on the Sysmex XP 300. TP (3) performs patient testing on the Sysmex XP 300. b. For the year 2019, the laboratory did not have training and competency assessments for (TP -3) for hematology testing using the new methodology of the automated Sysmex XP300 analyzer. c. For the laboratory Technical Consultant (TP- 1), the laboratory did not have documentation of annual competency for 2018 or 2019 as a testing personnel or as a technical consultant. d. The laboratory did not have competency assessments for 6 months competency for all three testing personnel for 2019 for the new methodology of automated hematology being performed on the Sysmex hemotology analyzer which was initiated in February of 2019 with releasing of patient test results on July 1, 2019. e. The laboratory manager confirmed by interview the lack of competency testing policys and procedures and proformance of initial, (6) month and annual competency's for testing personnel. f. The laboratory reports performing approximately (275) hematology, 200 mycobacteriology and (100) bacterology patient specimens annually. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on interview with testing personnel and record review of the laboratory's hematology calibration and verification logs on November 14, 2019, the laboratory failed to have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, and differant instruments. The -- 3 of 7 -- findings included: a. The laboratory currently performs hemoglobin and hematocrit (H&H) manually, and through automatic means on two sysmex hematology analyzers. b. The laboratory does not have documentation of comparing the results between the manual testing system and the automated testing systems. c. The laboratory does not have documentation of comparing the results between the two automated hematology analyzers for performing H&H and Complete Blood Counts. d. The laboratory testing personnel and the laboratory manager confirmed by interview on November 14, 2019 at approximately 12:00 p.m., the lack of performing and documentation of comparison testing between manual and automated testing methods and comparison of results between the two automated hematology analyzers twice annually. e. The laboratory reports performing approximately 275 hematology patient tests annually. 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 the systemic nature of deficienies cited and the lack of oversight for profiency testing enrollment and reporting, lack of training and competency of staff upon initiation of new testing methodologies, and annual competency of testing personnel and consultants, the laboratory director failed to provide the overall management and direction with 493.1407 of this subpart. The findings included: a. The laboratory director failed to ensure that laboratory enrolled and participates in an HHS approved proficiency testing program prior to testing and releasing patient speciems. See D2000, D2001 b. The Laboratory director failed to attest that proficiency testing is tested in the same manner as patient testing, that interlaboratory communication did not occurr. See D2009 c. The laboratory director failed to ensure that policy's and procedures are established for monitoring competency of all personnel engaged in preanalytic, analytic and postanalytic testing, and consultant competency. See D5209, D6055 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 testing records, proficiency testing (PT) enrollment records and interview with the laboratory manager on November 14, 2019, the laboratory director failed to ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. The findings included: a. The laboratory testing menu reports performing Complete Blood Counts (CBC), Hemoglobin & Hematocrit (H&H), Bacteriology and Mycobacteriology patient -- 4 of 7 -- specimens. b. The laboratory records PT enrollment with (CAP) and (API) in 2018 for Mycobacterium (MTB) and in 2019 for Mycobacterium identification and resistance; N. gonorrhea, C. trachomatis (NG/CL) identification. c. The laboratory had no documentation of enrollment for MTB, or NG/CL for event (1) of 2019. d. The laboratory reports initiating patient testing and reporting of patient hematology specimens on July 1, 2019. The laboratory has no documentation of enrollment or testing of PT samples for 2019. e. The laboratory manager and testing personnel confirmed by interview on November 14, 2019 at approximately 12:00 p.m. the lack of enrollment and testing of PT for event 1 of 2019 for mycobacterium and NC/CL, and the lack of enrollment and testing of PT prior to initiating and reporting patient samples in 2019. f. The laboratory reports performing approximately 200 Mycobacterium, 100 NG/CL, and 275 Hematology patient specimens annually. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of the laboratory's testing methodology's and interview with the technical consultant on November 14, 2019, the laboratory director failed to ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. The findings included: a. The laboratory director must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency see D5209 D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. -- 5 of 7 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's training and competency records and personnel interview on November 14,2019, the laboratory director failed to identify and specify in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. The findings included: a. The laboratory CMS-209 identifies (3) testing personnel who perform moderate complexity testing, and (2) phlebotomists who perform preanalytic testing activities and waived testing. b. The laboratory does not have documentation of training and competency for (2) of (3) of the moderate complexity testing personnel and no documentation of training and competency for the (2) preanalytic- waived testing personnel. c. The three moderate testing personnel all perform Complete Blood Counts (CBC) on the Sysmex hematology analyzers. There was no writted documentation as to the responsibilities and authorizations as to the authorization for release of patient results of those performing the hematology testing. There was no documentation of degree of review that is required prior to reporting of patient test results for waived testing. d. The laboratory manager and testing personnel confirmed by interview that the laboratory did not have written documentation specifying the responsibilities and duties of each testing personnel, and the degree of review requirements prior to releasing of patient test results. e. The laboratory reports performing approximately 275 hematology, and approximately 200 MTB, and approximately 1000 waived tests performed annually. D6055 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 whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 testing personnel, maintenance logs and interview with testing personnel on November 14, 2019, the technical consultant failed to evaluate and document the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results: a. The laboratory's CMS-209 testing personnel form lists three testing personnel (TP-1), (TP- 2), (TP-3). d. In 2018 the laboratory added the subspecialty bacteriology for N. gonorrheae and C. trachomatis to their testing menu, the laboratory did not have documentation of competency assessments for TP-1 or TP-2 for initial, (6) month or annual competency performance for 2018. e. The laboratory did not have competency assessments for initial competency for all three testing personnel for 2019 after implementing the new Sysmex XP 300 hematology analyzers in July of 2019. f. The laboratory technical consultant confirmed by interview the lack of competency testing policies and procedures and documentation of performance for initial, (6) month and -- 6 of 7 -- annual competency's for testing personnel. g. The laboratory reports performing approximately (275) hematology, 200 mycobacteriology and (100) bacteriology patient specimens annually. -- 7 of 7 --