Biological Laboratory, Inc

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's AAB- Medical Laboratory Evaluation (AAB- MLE) proficiency testing (PT) records, seven (7) randomly chosen patients sampling, and interviews with the laboratory's laboratory director (LD), technical supervisor (TS), and testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for ANA Panel; AE and ANA Fluorescent Pattern for the second event of 2025 (Q2-2025). The findings included: 1. The AAB-MLE proficiency program gave an unsatisfactory score of 60% for both: ANA Panel; AE and ANA Fluorescent Pattern for Q2-2025. 2. The TS and TP confirmed on October 23, 2025, at approximately 11:25 a.m. that the laboratory received the above proficiency score of 60% for ANA Panel and ANA Fluorescent Pattern as described in 1. 3. From two (2) out of seven (7) patients test results reviewed, ANA test results had been reported during the time the PT survey was unacceptable for which results cannot be assured. 3. Based on the laboratory's annual testing declaration submitted on the day of the survey October 20, 2025, the laboratory tested and reported approximately 1,707 General Immunology tests including ANA. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing 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 -- event. This STANDARD is not met as evidenced by: Based on the review of the College of American Pathology (CAP) proficiency testing (PT), the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, seven (7) randomly selected patient test records, and interviews with the laboratory's laboratory director (LD), technical supervisor (TS), and testing personnel (TP); the laboratory failed to attain a score of at least 80 percent of acceptable responses for the chemical analyte Vitamin B12 for the second event in 2025 (Q2-2025). The findings include: 1. Review of PT records for Q2-2025, CAP reported an unsatisfactory score report for Vitamin B12 chemical analyte of 60%. 2. The LD, TS, and TP confirmed by interview on October 23, 2025, at approximately 12:30 p.m. that the laboratory obtained the PT score mentioned in statements #1. 3. According to the laboratory's testing declaration submitted on the day of the survey October 23, 20255 and signed by the LD on 10/22/2023, the laboratory performed and reported approximately 24,338 Vitamin B12 patient laboratory test samples during the time the laboratory received unsatisfactory proficiency testing results. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the College of American Pathologists proficiency testing (PT) records, PT documentation, and interviews with the laboratory's laboratory director (LD), technical supervisor (TS), and testing personnel (TP); the laboratory failed to attain at least 80 percent of the acceptable score in Endocrinology for the Estradiol Sex Hormone analyte for the second PT event of 2025 (Q2-2025). The findings include: 1. CAP (Q2-2023), Estradiol Sex Hormone analyte = overall score: 60% Specimen Reported Expected Y-06 44 34 - 64 Y-07 5800 1964 - 3649* Y- 08 823 548- 1019 Y-09 225 149 - 278 Y-10 4081 1430 - 2658* * = unsatisfactory score reported 2. The LD, TS, and TP affirmed by an interview on October 23, 2025, at approximately 12:10 p.m. that the laboratory obtained the unsatisfactory PT scores for Estradiol for Q2-2025 event as mentioned in statement #1. 3. According to the laboratory's testing declaration, the laboratory performed and reported approximately 4,766 patient test samples for Estradiol Sex Hormone annually including the time the laboratory received unsatisfactory proficiency testing scores. Thus, the accuracy and reliability of patient test reported cannot be determined. D2109 TOXICOLOGY CFR(s): 493.845(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the second quarter event in 2025 (Q2-2025) of the laboratory's College of America Pathology (CAP) proficiency testing (PT) records, seven (7) randomly chosen patients sampling, and interviews with the laboratory's laboratory director (LD), technical supervisor (TS), and testing personnel (TP); the laboratory failed to attain a score of at least 80 percent of acceptable responses for the analyte Digoxin. The findings included: 1. CAP reported for Q2-2025, an unsatisfactory PT score for Digoxin analyte of 60% which is an unsatisfactory PT score. 2. The LD, TS, and TP affirmed on October 23, 2025, at approximately 12:00 p.m. that the laboratory received the above unsatisfactory proficiency test scores. 3. Based on the test volume declaration signed by the laboratory director on 08/23/2025, the laboratory tested 216 Digoxin annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the surveyor's review of the proficiency testing results documentation, randomly selected patient test records, and interviews with the laboratory personnel on October 23, 2025; the laboratory director is herein cited due to failure to ensure that several aspects of the analytic phases of the laboratory testing were monitored. The findings include: D2075, D2087, D2098, and D2109. -- 3 of 3 --

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) records, interview with the technical supervisor (TS), and testing personnel (TP); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent which is unsatisfactory performance. The findings included: 1. On the date of the survey October 5, 2021 at approximately 3:00 p..m. based on review of the PT scores, the laboratory obtained for Hematology WBC first event for the year 2021 (Q-1 2021) an overall score of 0% and for Prothrombin Time Quantitative (PT- Q) for the second event of 2021 (Q2-2021) a score of 40%. The results were as follow: WBC Overall score 0% Sample Reported Expected Score 1 22.9 14.6 - 19.9 U 2 3.7 2.4 - 3.3 U 3 10.1 6.4 - 8.7 U 4 8.7 5.6 - 7.7 U 5 3.6 2.4 - 3.4 U PT-Q Overall score 40% Sample Reported Expected Score 6 34.8 37.6 - 51.0 U 7 19.5 19.7 - 26.8 U 8 10.0 A 9 35.5 37.4 - 50.8 U 10 10.0 9.0 - 12.3 U 2. The TS and TP affirmed on 08/05 /2021at approximately 3:30 p.m. that the laboratory obtained the PT scores in 1. 3. According to the laboratory testing declaration submitted on the day of the surve , the laboratory performed approximately 145,832 Hematology samples (quarterly) during the time the laboratory received unsatisfactory PT performance scores. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the of the laboratory's SARS-CoV-2 RNA (COVID-19) Polymerase Chain Reaction (PCR) testing, and interviews with the technical supervisor (TS) and testing personnel (TP) on October 5, 2021 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the molecular amplification procedures which are not contained in closed systems have a unidirectional flow with separate areas for specimen preparation, RNA extraction, amplification, and product detection. The findings included: 1. The laboratory performed PCR testing for the presumptive detection of SARS-CoV-2 using the COVID-19 PCR Combo kit and amplification method on the BioRad instrument. 2. During the laboratory tour on 10/5/2021at approximately 1:00 p.m. the surveyor observed that RNA extraction and sample template addition were all performed in the same area of Cytology sample processing without unidirectional flow. 3. The TS and TP confirmed by interview on October 5, 2021 that the laboratory's molecular PCR testing for the presumptive detection of SARS-CoV-2 RNA was not set up in an unidirectional flow area. 4. Based on laboratory records, the laboratory performed and reported approximately 130,582 SARS-CoV-2 Real Time PCR molecular diagnostic tests annually. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies and procedures, ten (10) randomly chosen patient samples, and quality assurance records; and interview with the technical supervisor (TS) and testing personnel (TP) on October 5, 2021, it was determined that the laboratory failed to have a system in place to ensure that all complaints are investigated and documented . The findings included: 1. The laboratory did not have any system in place to investigate and document complaints by sample submitters as well as by the laboratory staff. 2. The TS and TP afirmed on October 5, 2021 at approximately 3:30 p.m. that the laboratory did not have any system in place to investigate and document all complaints. 3. According to the laboratory sample volume declaration at the time of the survey, the laboratory performed 1,700,312 samples annually. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as -- 2 of 3 -- acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the labortory tour, lack of calibration records, and interview with the laboratory technical supervisor (TS) and testing personnel (TP); it was determined that the laboratory failed to follow the BioTek manufacturer's instructions on the use of a calibration plate provided by the manufacturer. The findings included: 1. The laboratory used the BioTek flourescent wavelenght reader for various ELISA and EIA General Immunology test procedures. 2. The laboratory did not have available the calibration plate provided by the manufacturer or documenttion of performing calibration on the instrument. 3. The TS and TP affirmed on October 5, 2021 at approximately 12:45 p.m. that no calibration was performed on the BioTek instrument since relocation on the laboratory to the current location six (6) years ago. . 5. According to the testing volume declaration at the time of the survey, the laboratory performed 46,984 Gerneral Immunology samples annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's records for policies and procedures, proficiency testing results, lack of calibration documentation, and interview with the technical supervisor and laboratory personnel on October 5, 2021; it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of laboratory testing were monitored. See D2122, D5437, and D5205. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on the surveyor's direct observations of the laboratory's SARS-CoV-2 PCR testing processes and interview with the laboratory supervisor and testing personnel on October 5, 2021; the laboratory director failed to ensure that the physical plant and environmental conditions of the laboratory were appropriate for the testing performed. Findings include: See D3005. -- 3 of 3 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) 2017 thru 2019 test result reports, and interview with the laboratory technical consultant (TC) and the laboratory manager (LM), it was determined that the laboratory failed to attain a score of at least 80 percents of acceptable responses for Partial Thromboplastin Time (PTT) in the first 2019 PT event excluding a PT desk review by this office on January 9, 2019 and closed the case on January 14, 2019. The findings included: a. The laboratory used Sysmex CA1500 to perform coagulation testing including PTT. b. In order to be in compliance for the accuracy of the PTT testing system annually, the laboratory enrolled its PT with American Association of Bioanalysts (AAB) PT provider. c. The laboratory attained score of 60 % for PTT in the first (Q1) PT 2019 event, which was unsatisfactory performance for the event. d. The laboratory performed PTT in approximately 240 patient specimens per month. e. The TC and LM affirmed (9/12 /2019 @ 2:10 PM) that the laboratory attained score of 60 % for PTT in the first (Q1) 2019 PT, which was unsatisfactory performance for the PT event. 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. 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 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory's digital thermometer (DT) displays, a Fisher Brand, review of the temperature records, and interview with the laboratory technical consultant (TC), the laboratory manager (LM) and the laboratory personnel (TP), it was determined that the laboratory failed to follow the manufacturer's instructions and to familiarize the digital thermometers features and functions, and in a manner that provides temperature recording within the laboratory's stated performance specifications for daily temperature monitoring and recordings. The findings included: a. The laboratory selected a DT to monitor its temperatures condition of the refrigerator and freezer storages. b. The DT is equipped with features, namely to indicate the following information: 1) current temperature; 2) "Min", the lowest temperature in the past (not know exact time in the past), 3) "Max", the highest temperature in the past (not know exact time), or 4) "Lo" and 5) Hi" a mode to set the acceptable temperature ranges for the storage conditions, and 6) reset. c. The laboratory has established an acceptable temperature range for the refrigerator storage condition between 2 to 8 Celsius (oC). d. At the time of survey (9/12/2019 @10:35 AM), observed a DT for the refrigerator #3, a "Min" temperature record indicated a 1.4 oC in the past, which was out of the acceptable temperature for refrigerator storage condition. e. Further observation of a DT for the freezer #2, a "Max" temperature was recorded at 4.9 oC which was outside of the laboratory's acceptable temperature range between -10 to -30 oC. f. Furthermore, the laboratory failed to indicate that the temperature conditions were monitored for all the Sundays, when the laboratory closed. g. The TC, LM and TP affirmed (9/12/2019 @ 11 AM) that the laboratory failed to properly train, monitor, and record the temperatures to maintain the storage temperature in acceptable conditions. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Liquid Chromatography-Mass Spectrophotometry (LC/MS) and Labgen Comtrom, a laboratory information system's (LIS) quality control (QC) records, and interview with the technical supervisor (TS), it was determined that the laboratory failed to follow its written QC policies and procedures (P&P) and previously validated performance specificities for its LC/MS testing systems and failed to monitor the accuracy and precision of the complete analytic process. The findings included: a. The laboratory used Shimazu model 8030 LC/MS and Labgen Comtrom, a LIS, to perform urine drug screen and confirmation and provided the concentrations of the confirmed analyte and finally generated a report for a total of 57 drugs and its metabolites. b. The laboratory performed three levels of -- 2 of 4 -- quality control, namely Low, Mid, and High QCs. c. The laboratory used Westgard QC rules to monitor, assess and accept the daily QC run. d. Review of a Levey Jennings Chart for Test 1032: 6-MAM with a period of 9/5/2019 to- 09/09/2019 for three levels. e. The charts provided graphic as well as summaries as follows: * W =Westgard (Fixed) D** = Displayed Data Level W* mean SD D** Mean SD 1 125.0 37.5 142.2 16.9 2 725.0 87.5 684.9 65.5 3 2000 500.0 1355.6 133.6 f. Cumulative points from previously data before 09/05/2019 clumped together showed solid bars for each level QC on LJ chart, the TS was unable to explain the data at the time of survey (9/12/2019 @ 2 PM). h. The laboratory must familiarize the results and data reprented on the LJ charts to evalue and assess the laboratory performances. D5781

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performance. (See D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Partial Thromboplastin time (PTT), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, PTT, as follows: 2018 Q1 2018 Q3 PTT 60% 60% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, PTT. 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 severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, PTT, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2130) -- 2 of 2 --