Hshs Good Shepherd Hospital Laboratory

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 CMS-209 (Laboratory Personnel Report), laboratory policies and procedures, lack of documentation, and interview with the laboratory representative; the laboratory failed to have a competency assessment policy and procedure in place to assess employee competency for one of one technical consultant (TC)/technical supervisor (TS)/general supervisor (GS). Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) revealed one TC performing moderate complexity duties for the specialties of chemistry and hematology. This same individual served as the TS and GS performing high complexity duties for the specialty of immunohematology. 2. Review of laboratory policies and procedures revealed the laboratory lacked a competency assessment policy and procedure to assess the competency of one of one TC/TS/GS. 3. Interview with the laboratory representative on 08/05/2025, at 1:31 pm, confirmed the laboratory failed to have a competency assessment policy and procedure in place to assess employee competency for one of one TC, TS, and GS. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 review of laboratory policies and procedures, laboratory records, Individualized Quality Control Plans (IQCPs), lack of documentation, and interview with the laboratory representative; the laboratory failed to have 31 of 31 standard operating procedures (SOPs) and two of two IQCPs reviewed, approved, signed, and dated by the current laboratory director (as noted on the CMS-209 Laboratory Personnel Report) for the specialties of chemistry, hematology, and immunohematology. Findings include: 1. Review of laboratory policy and procedure manuals revealed no laboratory director (LD) approval, including signature and date, by the current LD for the following 31 of 31 SOPs reviewed: i. Acetaminophen ii. Alanine aminotransferase iii. Albumin iv. Alkaline phosphatase v. Ammonia vi. Amylase vii. Aspartate aminotransferase viii. Bilirubin, total ix. Bilirubin, direct x. Blood Gas/Oximetry xi. Blood Urea Nitrogen xii. Calcium xiii. Carbon dioxide xiv. Coagulation xv. Creatinine xvi. Creatinine kinase xvii. Electrolytes xviii. Ethyl Alcohol xix. Glucose xx. Immunohematology xxi. Hematology xxii. Lactic acid xxiii. Lipase xxiv. Magnesium xxv. Phosphorus xxvi. Pro-BNP [B-type natriuretic peptide] xxvii. Protein, total xxviii. Salicylate xxix. Toxicology xxx. Troponin xxxi. Vancomycin 2. Review of laboratory records revealed no LD approval, including signature and date, by the current LD for the following two of two IQCPs reviewed: i. Drugs of Abuse Screen ii. HCG (human chorionic gonadotropin) 3. Interview with the laboratory representative on 08/06/2025, at 10:05 am, confirmed the laboratory failed to have 31 of 31 SOPs and two of two IQCPs reviewed, approved, signed, and dated by the current LD for the specialties of chemistry, hematology, and immunohematology. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, Individualized Quality Control Plans (IQCPs), direct observation, and interview with the laboratory representative; the laboratory failed to have the current test methodology listed for two of two IQCPs utilized for hCG (human chorionic gonadotropin) serum testing in the subspecialty of endocrinology and Drugs of Abuse (DoA) screening in the subspecialty of toxicology. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Developing and Implementing an Individualized Quality Control Plan", which stated, under "Purpose:": a) "The objective of the quality control (QC) process is to outline guidelines to determine how QC is performed for tests systems in the laboratory."; and b) "The laboratory director retains overall responsibility for ensuring that QC programs are established and maintained ...." 2. Review of laboratory IQCPs revealed the following test methodologies documented: Test: Test Methodology: hCG serum "Sure-Vue HCG Serum" DoA screen "Alere Triage Drugs -- 2 of 4 -- of Abuse Panel" 3. Direct observation upon a tour of the laboratory on 08/05/2025, at 1:40 pm, revealed the following test methodologies currently being utilized: Test: Test Methodology: hCG serum Cardinal Health DoA screen Profile-V / MedToxScan (Serial Number: 1920M1062 4. Interview with the laboratory representative on 08/06 /2025, at 3:05 pm, confirmed the laboratory failed to have the current test methodology listed for two of two IQCPs utilized for hCG serum testing in the subspecialty of endocrinology and DoA screening in the subspecialty of toxicology. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report), laboratory policies and procedures, employee competency records, lack of documentation, and interview with the laboratory representative; the technical consultant (TC) failed to evaluate and document the performance of two of six new testing personnel (TP) at least semiannually during the first year the TP tested patient specimens in the specialties of chemistry and hematology from their Date of Hire (DoH) through the date of survey, 08/06/2025. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) revealed six new TP (TP #2, TP #4, TP #5, TP #6, TP #8, and TP #9). 2. Review of laboratory policies and procedures revealed the procedure titled "Competency Assessment & Training Activities", which stated, under "Narrative:", "Frequency for assessing competency will be done initially at hire, six months from hire, and yearly." 2. Review of employee competency records revealed two of six new TP failed to have their competency evaluated and documented at least semiannually during the first year the TP tested patient specimens. DoH: 6-month: 1st Annual: TP #6 01/02/2024 09/20/2024 Not documented TP #8 05/17/2024 01/20/2025 Not documented 3. Interview with the laboratory representative on 08/06/2025, at 3:05 pm, confirmed the TC failed to evaluate and document the performance of two of six new TP at least semiannually during the first year the TP tested patient specimens in the specialties of chemistry and hematology from their DoH through the date of survey, 08/06/2025. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) (e)(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, Individualized Quality Control Plans (IQCPs), lack of documentation, and interview with the laboratory representative; the laboratory failed to have 31 of 31 standard operating procedures and two of two IQCPs reviewed, approved, signed, and dated by the current laboratory director (as noted on the CMS-209 Laboratory Personnel Report) for the specialties of chemistry, hematology, and immunohematology (See D5407). -- 3 of 4 -- D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the CMS-209 (Laboratory Personnel Report), laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory director (LD) failed to specify, in writing, the responsibilities and duties, including each individual engaged in the preanalytical, analytical, and postanalytical phases of testing, for one of one technical consultant (TC)/technical supervisor (TS) /general supervisor (GS) and nine of nine testing personnel (TP) listed on the CMS- 209. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) revealed one TC performing moderate complexity duties for the specialties of chemistry and hematology. This same individual served as the TS and GS performing high complexity duties for the specialty of immunohematology. 2. Review of the CMS-209 (Laboratory Personnel Report) revealed five TP (TP #1-5) performing high complexity testing for the specialty on immunohematology and moderate complexity for the specialties of chemistry and hematology. 3. Review of the CMS-209 (Laboratory Personnel Report) revealed four TP (TP #6-9) performing only moderate complexity testing for the specialties of chemistry and hematology. 4. Review of laboratory records failed to identify documentation that specified, in writing, the responsibilities and duties, including each individual engaged in the preanalytical, analytical, and postanalytical phases of testing, for one of one TC/TS/GS and nine of nine TP (TP #1-9). 5. Interview with the laboratory representative on 08/05/2025, at 3: 22 pm, confirmed the LD failed to specify, in writing, the responsibilities and duties, including each individual engaged in the preanalytical, analytical, and postanalytical phases of testing, for one of one TC/TS/GS and nine of nine TP listed on the CMS- 209. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Based on an off-site desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider the laboratory was found to be out of compliance with the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American 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 -- Proficiency Institute (API) Proficiency Testing (PT) records confirmed the initial unsuccessful PT performance for the hematology analyte white blood cell differential (WBC Diff) for two of three PT events in 2024 through 2025 (event two of 2024 and event one of 2025). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records the laboratory failed to achieve satisfactory performance for the hematology analyte white blood cell differential (WBC Diff) for two of three PT events in 2024 through 2025 (event two of 2024 and event one of 2025) resulting in the initial unsuccessful PT performance for WBC Diff. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-01-2025, the laboratory received the following unsatisfactory scores for the hematology analyte WBC Diff. WBC Diff. EVENT 2, 2024 - 16% Unsatisfactory EVENT 1, 2025 - 0% Unsatisfactory 2. Review of API PT evaluation reports for the hematology/coagulation event 2, 2024 and event 1, 2025 confirmed the initial unsuccessful performance for the hematology analyte WBC Diff. 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the hematology analyte white blood cell differential (WBC Diff) resulting in the laboratory's initial unsuccessful PT performance. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American -- 2 of 3 -- Proficiency Institute (API) Proficiency Testing (PT) records the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the hematology analyte white blood cell differential resulting in the laboratory's initial unsuccessful PT performance. Refer to D2130. -- 3 of 3 --

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 CASPER Report 0155D and review of American Proficiency Institute (API) records the laboratory failed to successfully participate in proficiency testing (PT) for the immunohematology analyte compatibility testing during events one and two of 2022. See D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Report 0155D and review of American Proficiency Institute (API) records the laboratory failed to successfully participate in proficiency testing (PT) for the immunohematology analyte compatibility testing during events one and two of 2022. Findings include: 1. Review of the CASPER Report 0155D ran on 10-3-2022 identified the initial unsuccessful PT performance for the specialty of immunohematology for compatibility testing. IMMUNOHEMATOLOGY Compatibility Testing - EVENT-1, 2022 = 80% - Unsatisfactory Compatibility Testing - EVENT-2, 2022 = 80% - Unsatisfactory 2. Review of API PT records confirmed the unsuccessful PT performance for compatibility testing during events one and two of 2022. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the technical supervisor (TS); the laboratory failed to enroll in proficiency testing (PT) for three of four General Immunology Infectious Mononucleosis Program Events for testing years 2021 and 2022. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the test menu, "HSHS Good Shepherd Hospital Laboratory Test Menu May 2022", which indicated the laboratory performs Infectious Mononucleosis testing. 2. Review of American Proficiency Institute (API) proficiency testing records revealed the laboratory failed to enroll in PT for Infectious Mononucleosis (IM) testing for Event 2, 2021, Event 3, 2021 and Event 1, 2022. 3. Review of requested test volume records revealed from 05/04/2020 through 01/28/2022 55 IM tests were performed. 4. Interview with the TS, on 05/04/2022, at 12:20 pm, confirmed the laboratory failed to enroll with API for IM challenges. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the technical supervisor (TS); the laboratory failed to achieve a satisfactory score for one of six proficiency testing (PT) events reviewed for the chemistry analyte, creatine kinase-MB isoenzyme (CK-MB) resulting in the unsatisfactory performance for event two of 2021. 1. Review of American Proficiency Institute (API) proficiency testing records revealed the laboratory received a score of zero percent for (CK-MB) on Event 2, 2021. 2. The laboratory failed to provide a documented

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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and communication with the PT vendor American Proficiency Institute (API); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the Specialty of Hematology during calendar year 2019. Findings include: 1. Review of the CASPER Report 155 on January 06, 2020 and communication with the PT vendor AAB at 12:20 PM, the initial unsuccessful PT performance was confirmed under the Specialty of Hematology Partial Thromboplastin Time (PTT). See D-2130. 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 surveyor review of CASPER Report 155 Proficiency Testing (PT) records, and communication with the PT vendor American Proficiency Institute (API); it was confirmed that the laboratory failed to successfully participate in the testing of PT samples under the Specialty of Hematology during calendar year 2019. Findings include: 1. Review of the CASPER Report 155 on January 06, 2020 revealed that the initial unsuccessful PT performance occurred under the Specialty of Hematology Partial Thromboplastin Time (PTT) during events 2 and 3 of 2019 as listed below: HEMATOLOGY PTT- EVENT -2, 2019 = 40% Unsuccessful PTT- EVENT -3, 2019 = 20% Unsuccessful 2. During a phone communication with the PT vendor API on January 06, 2020 at 12:20 PM, confirmed the PT failing scores. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with general supervisor (GS); the laboratory director failed to attest to the routine testing of proficiency testing (PT) samples in 2018 through 2019 for chemistry, immunohematology, and hematology. Findings Include: 1. Proficiency testing records from the American Proficiency Institute (API) were reviewed for 2017 through 2019. 2. Review of API PT records for hematology/coagulation, immunology/immunohematology, and core chemistry revealed the laboratory director failed to attest that PT samples were handled in the same manner as patient samples for the following events: Core Chemistry a. 2018 - Event 3 b. 2019 - Event 1 Hematology/Coagulation a. 2018 - Event 3 b. 2019 - Event 1 Immunology/Immunohematology a. 2018 - Event 3 b. 2019 - Event 1 3. On survey date 09-12-19, at 6:00 pm the findings were confirmed by the GS. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- 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 laboratory records and interview with the general supervisor (GS); the laboratory failed to successfully participate in proficiency testing (PT) for thyroid stimulating hormone and activated partial thromboplastin time (APTT) in the speciaties of chemistry and hematology. Findings include: 1. The laboratory failed to perform and document a