Pediatrics East, Inc-Germantown

Summary Statement of Deficiencies D0000 During a recertification survey performed on 11/04/24, the laboratory was found out of compliance with the following conditions: 493.801 Condition: Enrollment and testing of samples 493.1208 Condition: General immunology 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor 493. 1487 Condition: Laboratories performing high complexity testing; testing personnel 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 laboratory observation and staff interview during observation, review of the McKesson Consult Mononucleosis test kit instructions, review of a patient activity log, review of the laboratory's proficiency testing records, and exit interviews with staff, the laboratory used the McKesson Consult Mononucleosis test kit as a non- waived test and failed to enroll in proficiency testing for the Mononucleosis test in 2023 and 2024. The findings include: 1. Laboratory observation on 11/04/24 at 8:40 a. m. revealed the McKesson Consult Mononucleosis test kit used for patient testing. During observation, the lead testing person was asked whether the laboratory performed the test on whole blood, serum, or plasma. The lead testing person stated that she used the black device with the kit to collect the sample from a fingerstick if Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- she could not get enough blood for the capillary container. 2. A review of the McKesson Consult Mononucleosis test kit instructions revealed the following: The test kit was CLIA waived for whole blood and moderate for serum/plasma. Under the section TEST PROCEDURE, STEP 2: "For whole blood samples, use the 25 uL (red line) sample transfer pipette. For serum/plasma samples, use the 10uL (black line) sample transfer pipette." 3. A review of a patient activity log revealed the laboratory had tested approximately 364 patients using the McKesson Consult Mononucleosis test kit since 11/01/2023. 4. A review of the laboratory's proficiency testing records revealed the laboratory was not enrolled or participating in proficiency testing for the Mononucleosis analyte in 2023 or 2024. 5. During an interview on 11/04/24 at 12:30 p.m., the technical consultant and laboratory liaison confirmed the laboratory used the McKesson Consult Mononucleosis test kit in a manner inconsistent with the manufacturer's requirements, resulting in a high-complexity laboratory-developed test and further confirmed the laboratory was not enrolled in proficiency testing for the Mononucleosis analyte in 2023 and 2024. Word Key: CLIA=Clinical Laboratory Improvement Amendments uL=microliter D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the CellDyn Emerald Quality Control package insert and staff interview, the laboratory failed to follow posted safety signage when it stored beverages intended for patient consumption in the same refrigerator as Complete Blood Count (CBC) controls and urine samples on the survey date. The findings include: 1. Laboratory observation on 11/04/24 at 8:40 a.m. revealed the following: Refrigerator number two was labeled with a sign that read "No food or drink." A container with cans of Sprite labeled as patient use only was in the refrigerator. CellDyn Emerald CBC quality controls were observed in the same refrigerator. 2. A review of the CellDyn Emerald CBC control package insert revealed the following: "CAUTION: This product contains human sourced and/or potentially infectious components." 3. The laboratory liaison stated during an interview on 11/04 /24 at 8:40 a.m. that the laboratory also stored samples for urine culture in refrigerator two and confirmed the survey findings. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on laboratory observation, a review of the manufacturer's package insert for the McKesson Consult Mononucleosis test kit, lack of documentation, and staff interviews, the laboratory failed to establish performance specifications for the laboratory-developed high-complexity Mononucleosis test when it used the test in a -- 2 of 15 -- manner inconsistent with the manufacturer's requirements (Refer to D5423) and failed to perform negative and positive quality control each day of patient testing for the non- waived McKesson Consult Mononucleosis test (Refer to D5449). D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation, review of manufacturer instructions for use, and staff interview, the laboratory failed to label three of three CBC controls with an open date and corrected expiration date on the survey date (11/04/24). The findings include: 1. Laboratory observation on 11/04/24 at 8:40 a.m. revealed three levels of CBC controls (Lot number 4260, Low, Normal, and High vials) that were not labeled with an open date or corrected expiration date. 2. A review of the Abbott CellDyn control package insert revealed the controls were stable for eight consecutive days of use after opening. 3. During an interview on 11/04/24 at 8:40 a.m., the lead testing person stated that the controls were opened the day before the survey and that the person who opened them did not label them. This confirmed the survey findings. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the manufacturer's package insert for the McKesson Consult Mononucleosis test kit, review of patient test reports, lack of documentation, and staff interviews, the laboratory failed to establish performance specifications for the laboratory-developed high-complexity Mononucleosis test when it used the test in a manner inconsistent with the manufacturer's requirements. 1. Laboratory observation on 11/04/24 at 8:40 a.m. revealed the McKesson Consult Mononucleosis test kit used for patient testing. During observation, the lead testing person was asked whether the laboratory performed the test on whole blood, serum, or plasma. The lead testing person stated that she used the black device with the kit to collect the sample from a fingerstick if she could not get enough blood for the capillary container. The lead testing person could not provide any specific patient -- 3 of 15 -- tested using this method. 2. A review of the McKesson Consult Mononucleosis test kit instructions revealed the following: The test kit was CLIA waived for whole blood and moderate for serum/plasma. Under the section TEST PROCEDURE, STEP 2: "For whole blood samples, use the 25 uL (red line) sample transfer pipette. For serum /plasma samples, use the 10uL (black line) sample transfer pipette." 3. A review of patient test reports revealed testing for Mononucleosis reported on 11/21/23 for patient 428258, on 01/06/24 for patient 77118, and on 03/07/24 for patient 447975. 4. There was no documentation that the laboratory established performance specifications for off-label use of the McKesson Consult Mononucleosis test. 5. The technical consultant and laboratory liaison confirmed the survey findings during an interview on 11/04/24 at 12:40 p.m. CLIA=Clinical Laboratory Improvement Amendments uL=microliter D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interview during observation, review of the McKesson Consult Mononucleosis manufacturer package insert, review of patient test results, review of quality control records, review of a patient activity log, and staff interview, the laboratory used the McKesson Consult Mononucleosis test in a manner that resulted in the test kit no longer meeting waived test criteria and failed to perform negative and positive quality control for the McKesson Consult Mononucleosis test kit each day of patient testing in 2023 and 2024 for three of three patients selected with approximately 364 patients reported since 11/01/2023. The findings include: 1. Laboratory observation on 11/04/24 at 8:40 a.m. revealed the McKesson Consult Mononucleosis test kit used for patient testing. During observation, the lead testing person was asked whether the laboratory performed the test on whole blood, serum, or plasma. The lead testing person stated that she used the black device with the kit to collect the sample from a fingerstick if she could not get enough blood for the capillary container. The lead testing person could not provide any specific patient tested using this method. 2. A review of the McKesson Consult Mononucleosis test kit instructions revealed the following: The test kit was CLIA waived for whole blood and moderate for serum/plasma. Under the section TEST PROCEDURE, STEP 2: "For whole blood samples, use the 25 uL (red line) sample transfer pipette. For serum /plasma samples, use the 10uL (black line) sample transfer pipette." 3. A review of patient test reports revealed testing for Mononucleosis reported on 11/21/23 for patient 428258, on 01/06/24 for patient 77118, and on 03/07/24 for patient 447975. 4. A review of the laboratory's quality control records for the Mononucleosis test revealed that negative and positive quality control was not performed on 11/21/23, 01 /06/24, or 03/07/24. 5. The technical consultant and laboratory liaison confirmed during an interview on 11/04/24 at 12:30 p.m. that the laboratory did not perform negative and positive QC each day of patient testing for the non-waived Mononucleosis test. CLIA=Clinical Laboratory Improvement Amendments uL=microliter -- 4 of 15 -- D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on laboratory observation and staff interview during observation, review of the McKesson Consult Mononucleosis test kit instructions, lack of documentation, and staff interview, the laboratory used the McKesson Consult Mononucleosis test kit as a laboratory-developed test and failed to have a laboratory director qualified to direct high-complexity testing (Refer to D6078). D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director 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) Be a doctor of medicine, a 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)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interview during observation, review of the -- 5 of 15 -- McKesson Consult Mononucleosis test kit instructions, lack of documentation, and staff interview, the laboratory used the McKesson Consult Mononucleosis test kit as a high-complexity laboratory-developed test and failed to have a laboratory director qualified to direct high-complexity testing. The findings include: 1. Laboratory observation on 11/04/24 at 8:40 a.m. revealed the McKesson Consult Mononucleosis test kit used for patient testing. During observation, the lead testing person was asked whether the laboratory performed the test on whole blood, serum, or plasma. The lead testing person stated that she used the black device with the kit to collect the sample from a fingerstick if she could not get enough blood for the capillary container. The lead testing person could not provide any specific patients tested performed using the black sample transfer pipette. 2. A review of the McKesson Consult Mononucleosis test kit instructions revealed the following: The test kit was CLIA waived for whole blood and moderate for serum/plasma. Under the section TEST PROCEDURE, STEP 2: "For whole blood samples, use the 25 uL (red line) sample transfer pipette. For serum/plasma samples, use the 10uL (black line) sample transfer pipette." 3. No documentation that qualified the laboratory director to direct high-complexity testing was available on the survey date. 4. The technical consultant and laboratory liaison confirmed the survey findings during an interview on 11/04/24 at 12:30 p.m. CLIA=Clinical Laboratory Improvement Amendments uL=microliter D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on laboratory observation and staff interview during observation, review of the McKesson Consult Mononucleosis test kit instructions, lack of documentation, and staff interview, the laboratory used the McKesson Consult Mononucleosis test kit as a laboratory-developed test and failed to have a technical supervisor qualified to perform technical supervision of high-complexity testing in immunology (Refer to D6111) D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is 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)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(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 (c)(1)(ii) Be certified in -- 6 of 15 -- clinical pathology 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 (c)(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 (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(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 (d)(1)(ii) Be certified in clinical pathology 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 (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which -- 7 of 15 -- the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology 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 (e) (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 (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology 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 (f)(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 (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which -- 8 of 15 -- the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology 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 (g) (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 (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology 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 (h)(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 (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(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 (i)(1)(ii) Be certified in clinical pathology 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 (i)(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 -- 9 of 15 -- located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology 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 (j)(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 (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology 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 (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology 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; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a -- 10 of 15 -- training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) 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-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology 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 (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) 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-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology 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 (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology 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 (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology 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 (n)(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 (n)(2)(ii) Have at least 1 year of laboratory training or -- 11 of 15 -- experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(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 (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(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 (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology 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 (q)(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 (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor 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. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high -- 12 of 15 -- complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interview during observation, review of the McKesson Consult Mononucleosis test kit instructions, lack of documentation, and staff interview, the laboratory used the McKesson Consult Mononucleosis test kit as a high-complexity, laboratory-developed test and failed to have a technical supervisor qualified to perform technical supervision of high-complexity testing in immunology. The findings include: 1. Laboratory observation on 11/04/24 at 8:40 a.m. revealed the McKesson Consult Mononucleosis test kit used for patient testing. During observation, the lead testing person was asked whether the laboratory performed the test on whole blood, serum, or plasma. The lead testing person stated that she used the black device with the kit to collect the sample from a fingerstick if she could not get enough blood for the capillary container. The lead testing person could not provide any specific patients tested performed using the black sample transfer pipette. 2. A review of the McKesson Consult Mononucleosis test kit instructions revealed the following: The test kit was CLIA waived for whole blood and moderate for serum /plasma. Under the section TEST PROCEDURE, STEP 2: "For whole blood samples, use the 25 uL (red line) sample transfer pipette. For serum/plasma samples, use the 10uL (black line) sample transfer pipette." 3. No documentation that qualified personnel as a technical supervisor in immunology was available on the survey date. 4. The technical consultant and laboratory liaison confirmed the survey findings during an interview on 11/04/24 at 12:30 p.m. CLIA=Clinical Laboratory Improvement Amendments uL=microliter D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on laboratory observation, review of the manufacturer package insert, a lack of documentation and staff interviews, testing personnel performing the McKesson Consult Mononucleosis test as a laboratory-developed, high-complexity test did not qualify (Refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 -- 13 of 15 -- semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i

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 Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two out of three PT events for the automated white blood cell (WBC) differential (DIFF) resulting in the first unsuccessful PT occurrence for the WBC DIFF analyte. (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 2 -- 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 desk review of the CMS 155 and the laboratory's 2023 API PT evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the automated WBC DIFF analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory WBC DIFF scores: 2023 Event one 60% 2023 Event three 73% 2. Review of the API PT evaluation report for 2023 Event one revealed an overall score of 60% for the WBC DIFF analyte. 3. Review of the API PT evaluation report for 2023 Event three revealed an overall score of 73% for the WBC DIFF analyte. -- 2 of 2 --

Summary Statement of Deficiencies D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on observations of the laboratory, record review and staff interview, the technical consultant failed to review and approve quality assessment/quality control records in 2019, 2020 and 2021. The findings include: 1. Observations of the laboratory on 12.7.21 at approximately 9:20 am revealed moderately complex patient testing was being performed as follows: microscope for pinworm and urine microscopy, Cell DYN Emerald (serial number 7302) for complete blood count (CBC) and incubator for urine colony counts. 2. Review of monthly quality assurance /quality control records revealed no review by the previous technical consultant from June 2019 through July 2021. 3. Interview with lead TP on 12.7.21 at approximately 4: 20 pm confirmed the previous technical consultant failed to review and approve quality assurance/quality controls records from June 2019 through July 2021. 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 2 -- This STANDARD is not met as evidenced by: Based on observations of the laboratory, review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), review of testing personnel competency records and staff interview, the previous technical consultant failed to evaluate the competency for eight of eight testing personnel (TP) in 2020 and 2021. The findings include: 1. Observations of the laboratory on 12.7.21 at approximately 9:20 am revealed moderately complex patient testing was being performed for pinworm and urine microscopy, complete blood count (CBC), and urine colony counts. 2. Review of the Form CMS-209 revealed eight TP performed moderately complex testing. 3. Review of competency assessment records revealed eight of eight TP annual competencies were not performed and reviewed by the previous technical consultant in 2020 and 2021. 4. Interview with lead TP on 12.7.21 at approximately 4:20 pm confirmed the previous technical consultant failed to perform and review competency assessment for eight of eight TP in 2020 and 2021. -- 2 of 2 --

Summary Statement of Deficiencies 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 policy for testing personnel, the form used for documenting testing personnel competency assessment and interview with the laboratory coordinator, the laboratory failed to follow policy for testing personnel competency assessment in 2018. The findings include: 1. Review of the laboratory's policy for testing personnel revealed that competency assessment would be performed using direct observation of patient testing, monitoring recording and reporting of test results, review of intermediate test results or worksheets, direct observation of instrument maintenance and function checks, blind testing and problem solving skills. 2. Review of the form used for documenting testing personnel competency assessment revealed that direct observations and blind testing was not included as part of the competency assessment for complete blood count, urine colony count, urine microscopy, and pinworm prep. 3. Interview with the laboratory coordinator on August 28, 2018 at 2pm confirmed the laboratory failed to follow the testing personnel policy for competency assessment when it did not include direct observation and blind testing as part of competency assessment 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 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 -- through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assessment (QA) plan, the manufacturer package insert for quality control (QC) lot number L8127, the laboratory QC report for lot number L8127, the complete blood count (CBC) instrument maintenance log for June 2018, patient numbers one, two, and three test reports, and proficiency testing attestation statements for 2018 events one and two, the June 2018 quality assessment form and interview with the laboratory coordinator, the laboratory's quality assessment process was ineffective when it failed to detect problems with QC target assignment and personnel performing testing with no prior documented training in 2018. 1. Review of the laboratory's QA plan revealed the following definition: To monitor and evaluate the ongoing and overall quality of the total testing process by evaluating all established policies and procedures for their effectiveness, identifying and correcting problems, assuring accurate, reliable and prompt test reports and assuring adequacy and competency of the staff. This includes the entire testing process from patient preparation and specimen collection, test analysis and reporting of test results. To qualify as testing personnel a high school diploma and documented training is required. 2. Review of the manufacturer package insert for quality control lot number L8127 revealed an acceptable target value of 17.5% for the hematocrit analyte. 3. Review of the laboratory's QC report for lot number L8127 revealed a target value of 17.3% in use for the hematocrit analyte, and in use dates from 6.1.2018 to 8.24.2018. 4. Review of the Cell-dyn Emerald complete blood count (CBC) instrument maintenance log for June 2018, patient numbers one, two, and three test reports for pinworm prep and CBC performed in June 2018, and the laboratory's proficiency testing attestation statements for 2018 events one and two revealed maintenance, patient testing, and proficiency testing performed by multiple testing personnel with no prior documented training. 5. Review of the June 2018 form used for recording quality assessment activities revealed signatures of both the laboratory coordinator and the laboratory director/technical consultant with no documentation of