Advanced Clinical Laboratory

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Advanced Clinical Laboratory, CLIA ID 19D1034225, on August 23, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the manufacturers' storage requirements, and interview with personnel, the laboratory failed to monitor the room temperature of the storage room where laboratory supplies were stored. Findings: 1. Observation by surveyor during the laboratory tour on August 23, 2024 at 9:25 am revealed the following items stored in a storage room located behind the storage area: a) BD Vacutainer serum blood collection tubes b) BD Vacutainer K2EDTA blood collection tubes c) Aptima Unisex Swab specimen collection kits d) UTM RT specimen collection kit for viruses, Chlamydia, Mycoplasma, Ureaplasma 2. Review of the manufacturers' storage requirements revealed the following: a) BD Vacutainer serum blood collection tubes: storage temperature: 4-25 degrees Celsius b) BD Vacutainer K2EDTA blood collection tubes: storage temperature 4-25 degrees Celsius c) Aptima Unisex Swab specimen collection kits: storage temperature 15-30 degrees Celsius d) UTM RT specimen collection kits: 2-25 degrees Celsius 3. In interview on August 23, 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 -- 2024 at 9:25 am the Technical Consultant stated the room temperature was not monitored in the identified storage room. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturers' storage requirements, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5413. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturers' storage requirements, and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Refer to D5413. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Advanced Clinical Laboratory, CLIA # 19D1034225, on October 24, 2022. Advanced Clinical Laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.801 CONDITION: Enrollment and testing of samples 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 proficiency test recods, test menu, and interview with personnel, the laboratory failed to enroll in an HHS approved proficiency testing program for blood cell identification. Findings: 1. Initial review of the laboratory's test menu on October 24, 2022 at 9:40 am revealed the laboratory did not include manual differentials on their list of tests performed. 2. In interview on October 24, 2022 at 10: 30 am the Technical Consultant stated the laboratory performs manual differentials for Complete Blood Count testing. 3. Review of the laboratory's 2021 and 2022 proficiency test records revealed the laboratory was not enrolled in an HSS approved proficiency testing program for blood cell identification. 4. In further interview on Ocotber 24, 2022 at 3:59 pm, the Technical Consultant confirmed the laboratory was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- not enrolled in a proficiency testing program for blood cell identification. 5. Review of the laboratory's updated test menu revealed the laboratory performs 1,057 manual differentials annually. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration records and interview with personnel, the laboratory failed to retain one (1) of three (3) calibration records reviewed for the Complete Blood Count (CBC) analyzer for at least two (2) years. Findings: 1. Review of the laboratory's calibration records for the CBC analyzer revealed the laboratory did not retain the records for May 2022. 2. In interview on October 24, 2022 at 3:37 pm, the Technical Consultant stated the laboratory keeps the latest calibration records. The Technical Consultant confirmed the laboratory did not retain the CBC analyzer's calibration records for May 2022. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a written quality control procedure for blood culture bottles that included visual inspections. 2. In interview on October 24, 2022 at 10:25 am, the Technical Consultant confirmed the laboratory did not have a procedure for visual inspections of blood culture bottles. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu, policies/procedures, and interview with personnel, the laboratory failed to ensure policies were updated to include current test procedures Findings: 1. Review of the laboratory's policies and procedures revealed policies related to urine drug screens (UDS) were included with current tests policies /procedures, not discontinued. 2. In interview on October 24, 2022 at 11:00 am Testing Personnel 1 stated UDS testing was discontinued in December 2019. Testing -- 2 of 6 -- Personnel 1 confirmed the laboratory's policies and procedures were not updated to current tests. 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 observation by surveyor, review of the manufacturer's package insert, and interview with personnel, the laboratory failed to document the visual inspection of blood culture bottles prior to use per manufacturer's requirements. Findings: 1. Observation by surveyor during the laboratory tour on October 24, 2022 at 10:15 am revealed the laboratory utilizes BacT/ALERT Adult Blood Culture Collection Kits (lot number 2206270017). 2. Review of the manufacturer's package insert revealed "Inspect each blood culture bottle before use to ensure integrity of bottle and sensor on bottom of bottle is intact. The sensor is normally a uniform grayish-green color and a yellow color would indicate contamination of the broth. Discard any bottle found to be damaged or with a sensor that is yellow." 3. In interview on October 24, 2022 at 10: 05 am, the Technical Consultant stated the laboratory checks the expiration dates of the blood culture bottles. The Technical Consultant confirmed the laboratory does not document visual inspections of the blood culture bottles received. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of maintenance records, and interview with personnel, the laboratory failed to ensure weekly maintenance for the Cobas e411 was performed per manufacturer's requirements for two (2) of three (3) weeks in October 2022. Findings: 1. Observation by surveyor during the laboratory tour on October 24, 2022 at 10:15 am revealed the laboratory utilizes the Cobas e411 for routine chemistry and endocrinology testing. 2. Review of the "Cobas e411 analyzer Maintenance log" revealed the following weekly maintenance tasks: a) Clean incubator and aspiration station b) Clean sipper probe 3. Further review of the "Cobas e411 analyzer Maintenance log" for October 2022 revealed the laboratory did not document weekly maintenance performance for the following weeks: Week of October 9, 2022 Week of October 16, 2022 4. In interview on October 24, 2022 at 3: 37 pm, the Technical Consultant confirmed the laboratory did not document the weekly maintenance performance for the identified two weeks. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 3 of 6 -- 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 observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D6014. 2. The Laboratory Director failed to ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. Refer to D6015. 3. The Laboratory Director failed to ensure that the laboratory performed required maintenance. Refer to D6023. 4. The Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D6031. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to retain one (1) of three (3) calibration records reviewed for the Complete Blood Count (CBC) analyzer for at least two (2) years. Refer to D3039. 2. The laboratory failed to document the visual inspection of blood culture bottles prior to use per manufacturer's requirements. Refer to D5411. 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 record review and interview with personnel, the Laboratory Director failed to ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. Refer to D2000. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) -- 4 of 6 -- 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on record review, and interview with personnel, the Laboratory Director failed to ensure that the laboratory performed required maintenance. Refer to D5429. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to ensure policies were updated to include current test procedures Refer to D5407. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Findings: 1. The laboratory failed to retain one (1) of three (3) calibration records reviewed for the Complete Blood Count (CBC) analyzer for at least two (2) years. Refer to D3039. 2. The laboratory failed to document the visual inspection of blood culture bottles prior to use per manufacturer's requirements. Refer to D5411. 3. The laboratory failed to ensure weekly maintenance for the Cobas e411 was performed per manufacturer's requirements for two (2) of three (3) weeks in October 2022. Refer to D5429. D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in -- 5 of 6 -- an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Consultant failed to ensure enrollment in an HHS approved proficiency testing program. Refer to D2000. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on June 14, 2018 at Advanced Clinical Laboratory-CLIA ID # 19D1034225. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to monitor the temperature of areas where laboratory supplies are stored per manufacturer requirements. Findings: 1. Observation by surveyor during the laboratory tour on June 14, 2018 revealed the laboratory did not monitor the temperature for the following areas: Storage area near Hematology analyzer Storage area for blood collection tubes 2. Review of the manufacturer requirements listed on the packaging revealed the following temperature requirements: a) Sychron systems No foam; 8-30 degrees Celsius b) Premier Hb 9210 Premier Buffer A; 2-28 degrees Celsius c) CTS Auto-Gloss; 8-30 degrees Celsius d) Premier Hb 9210 Premier Buffer B; 2-28 degrees Celsius e) Premier Hb 9210 Premier Wash; 2-28 degrees Celsius f) Cartridge Chem Wash Solution (CCWA); 8-30 degrees Celsius g) Beckman Coulter ISE Electrolyte Buffer, 8-30 degrees Celsius h) Beckman Coulter Albumin Reagent; 8- 30 degrees Celsius i) Beckman Coulter Creatinine Reagent; 8-30 degrees Celsius j) Beckman Coulter Sample Diluent 1; 8-30 degrees Celsius k) Beckman Coulter Direct 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 -- Bilirubin Reagent; 8-30 degrees Celsius l) Beckman Coulter Magnesium Reagent; 8- 30 degrees Celsius m) Beckman Coulter Phosphorus Reagent; 2-28 degrees Celsius n) Beckman Coulter Total Bilirubin Reagent; 8-30 degrees Celsius o) Iron/TIBC Cal Kit; 8-30 degrees Celsius p) Anti Foam; 8-30 degrees Celsius q) Beckman Coulter DxH Cleaner; 2-25 degrees Celsius r) Beckman Coulter DxH Diff Pack; 2-25 degrees Celsius s) Beckman Coulter Cell Lyse; 2-40 degrees Celsius t) Roche Assay Cup; 2- 32 degrees Celsius u) Roche Assay Tips, 2-32 degrees Celsius v) Beckman Coulter DxH Diluent; 2-40 degrees Celsius w) Monoject Covidien No Additive blood collection tubes; 0-40 degrees Celsius x) Covidien EDTA blood collection tubes; 0-40 degrees Celsius y) BD Vacutainer Sodium Heparin blood collection tubes; 4-25 degrees Celsius z) BD Vacutainer Sodium Fluoride/Potassium Oxalate blood collection tubes; 4-25 degrees Celsius aa) BD Vacutainer ACD Solution A blood collection tubes; 4-25 degrees Celsius bb) BD Vacutainer Buffered Sodium Citrate blood collection tubes; 4-25 degrees Celsius cc) BD Vacutainer EDTA blood collection tubes; 4-25 degrees Celsius dd) BD Vacutainer Serum blood collection tubes; 4-25 degrees Celsius ee) BD Vacutainer SST tubes; 4-25 degrees Celsius ff) BD Vacutainer Trace Element blood collection tubes; 4-25 degrees Celsius 3. Further observation during laboratory tour revealed the following items stored without room temperature monitoring: Storage area near Hematology analyzer: a) Sychron systems No foam, 1.0 L, Lot # M803221, Quantity 5; Lot # M801096, Quantity 2; Lot # M802198, Quantity 3; Lot # M712062, Quantity 4; Lot # M710058, Quantity 3; Lot # M71286, Quantity 2; Lot # M708160, Quantity 4; Lot # M70987, Quantity 5; Lot # M706049, Quantity 1 b) Premier Hb 9210 Premier Buffer A; 940 mL, Lot # 7855, Quantity 4; Lot # 8289, Quantity 7 c) CTS Auto-Gloss; 500 mL, Lot # M801022, Qty 1 d) Premier Hb 9210 Premier Buffer B; Lot # 7509, Quantity 1; Lot # 7864, Quantity 10 e) Premier Hb 9210 Premier Wash; Lot # 8133, Quantity 3; Lot # 8466, Quantity 2 f) Cartridge Chem Wash Solution (CCWA); Lot# M803016, Quantity 3 boxes g) Beckman Coulter ISE Electrolyte Buffer, Lot # M802707, Quantity 1 bottle; Lot # M803213, Quantity 2 boxes; Lot # M804058, Quantity 2 boxes; Lot # M804054, Quantity 1 box; Lot # M80404148, Quantity 1 box; Lot # 802200, Quantity 1 box h) Beckman Coulter Albumin Reagent; Lot # M803028, Quantity 2 boxes i) Beckman Coulter Creatinine Reagent; Lot M710007, Quantity 6 boxes, Lot # M709011, Quantity 1 box; Lot # M712020, Quantity 5 boxes; Lot # M712420, Quantity 3 boxes; Lot # M802021, Quantity 5 boxes; Lot # 801132, Quantity 6 boxes; Lot # M802481, Quantity 6 boxes; Lot # M803030, Quantity 6 boxes j) Beckman Coulter Sample Diluent 1; Lot # M803027, Quantity 8 boxes; Lot # M802015, Quantity 2 boxes k) Beckman Coulter Direct Bilirubin Reagent; Lot # M710016, Quantity 1 box; Lot # M612297, Quantity 2 boxes; Lot # M706075, Quantity 1 box; Lot # M710016, Quantity 1 box; Lot # 803019, Quantity 1 box; Lot # 704021, Quantity 2 boxes l) Beckman Coulter Magnesium Reagent; Lot # M803033, Quantity 2 boxes; Lot # M804038, Quantity 3 boxes m) Beckman Coulter Phosphorus Reagent; Lot # M70013, Quantity 1 box; Lot # M704027, Quantity 1 box n) Beckman Coulter Total Bilirubin Reagent; Lot # M801015, Quantity 16 boxes o) Iron/TIBC Cal Kit; Quantity 2 boxes p) Anti Foam; Quantity 8 q) Beckman Coulter DxH Cleaner; Quantity 3 boxes r) Beckman Coulter DxH Diff Pack; Quantity 6 boxes s) Beckman Coulter Cell Lyse; Quantity 3 boxes t) Roche Assay Cup; Quantity 3 boxes u) Roche Assay Tips, Quantity 5 boxes v) Beckman Coulter DxH Diluent; Quantity 36 boxes Storage area with blood collection tubes: a) Monoject Covidien No Additive blood collection tubes; Lot # 722825, Quantity 50 tubes b) Covidien EDTA blood collection tubes; Lot # 628646, Quantity 98 tubes c) BD Vacutainer Sodium Heparin blood collection tubes; Lot # 7279845, Quantity 80 tubes d) BD Vacutainer Sodium Fluoride /Potassium Oxalate blood collection tubes; Lot # 7100996, Quantity 50 tubes e) BD Vacutainer ACD Solution A blood collection tubes; Lot # 7255808, Quantity 120 -- 2 of 3 -- tubes f) BD Vacutainer Buffered Sodium Citrate blood collection tubes; Lot # 7346912, Quantity 90 tubes g) BD Vacutainer EDTA blood collection tubes; Lot # 8011928, Quantity 700 tubes h) BD Vacutainer Serum blood collection tubes;Lot # 7255765, Quantity 500 tubes i) BD Vacutainer SST tubes; Lot # 7321649, Quantity 300 tubes; Lot # 8047611, Quantity 100 tubes j) BD Vacutainer Trace Element blood collection tubes; Lot # 7340972, Quantity 80 tubes 4. In interview on June 14, 2018 at 9:15 am, Personnel 3 stated the temperature of the identified storage areas are not monitored. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Refer to D5413. -- 3 of 3 --