Medical Specialists Of The Palm Beaches Inc

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 05 /19/2026 for Medical Specialists of the Palm Beaches Inc. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2016 493.803(a)(b)(c) Condition: Successful Participation D6000 493.1403 Condition: Moderate Complexity 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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email 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 -- communication with the API PT program, the laboratory failed to successfully participate in the Subspecialty of Routine Chemistry for the analytes of Routine Chemistry, Alanine aminotransferase(ALT), Albumin (ALB), Alkaline phosphatase (Alk Phos), Amylase (Amy), Aspartate aminotransferase (AST), Total bilirubin (T Bili), Total Calcium (Ca), Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Chloride (Cl), Total Cholesterol (Chol), High density lipoprotein cholesterol (HDL), Low density lipoprotein direct measure cholesterol (LDL), Creatine kinase (CK), Creatinine (Creat), Ferritin (Ferr), Gamma glutamyl transferase (GGT), Glucose (Glu), Glycated Hemoglobin (Hgb A1C), Iron, Lactate dehydrogenase (LDH), Magnesium (Mg), Phosphorus (Phos), Potassium (K), Sodium (Na), Prostate Specific Antigen (PSA), Total protein (TP), Triglyceride (Trig), Blood Urea Nitrogen (BUN), Uric acid (UA), and Vitamin B12; failed to successfully participate in the Subspecialty of Endocrinology for the following analytes of Endocrinology, Folate, Free thyroxine (Free T4), Parathyroid Hormone (PTH), Triiodothyronine uptake (T3 Uptake), Testosterone (Test), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Thyroxine (T4); and failed to successfully participate in the Subspecialty of Toxicology for the following analytes of Toxicology, and Digoxin (Dig) for 2 out of 3 testing events in 2025 and 2026. Findings included: Review of the API proficiency testing records and the review of the CMS 153 and 155 reports, on 04/02 /2026 at 11:21 AM, the laboratory had unsatisfactory testing scores for the analytes of Routine Chemistry, Alanine aminotransferase(ALT), Albumin (ALB), Alkaline phosphatase (Alk Phos), Amylase (Amy), Aspartate aminotransferase (AST), Total bilirubin (T Bili), Total Calcium (Ca), Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Chloride (Cl), Total Cholesterol (Chol), High density lipoprotein cholesterol (HDL), Low density lipoprotein direct measure cholesterol (LDL), Creatine kinase (CK), Creatinine (Creat), Ferritin (Ferr), Gamma glutamyl transferase (GGT), Glucose (Glu), Glycated Hemoglobin (Hgb A1C), Iron, Lactate dehydrogenase (LDH), Magnesium (Mg), Phosporus (Phos), Potassium (K), Sodium (Na), Prostate Specific Antigen (PSA), Total protein (TP), Triglyceride (Trig), Blood Urea Nitrogen (BUN), Uric acid (UA), and Vitamin B12 (See D2096); for the following analytes of Endocrinology, Folate, Free thyroxine (Free T4), Parathyroid Hormone (PTH), Triiodothyronine uptake (T3 Uptake), Testosterone (Test), Triiodothyronine (T3), Thryoid Stimulating Hormone (TSH), and Thyroxine (T4) (See D2107); and for the following analytes of Toxicology, and Digoxin (Dig) (See D2118) for 2 out of 3 testing events in 2025 and 2026. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the API PT program, the laboratory failed to successfully participate in the Subspecialty of Routine Chemistry for the analytes of Routine Chemistry, Alanine aminotransferase(ALT), Albumin (ALB), Alkaline phosphatase (Alk Phos), Amylase (Amy), Aspartate aminotransferase (AST), Total bilirubin (T Bili), Total Calcium (Ca), Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), -- 2 of 5 -- Chloride (Cl), Total Cholesterol (Chol), High density lipoprotein cholesterol (HDL), Low density lipoprotein direct measure cholesterol (LDL), Creatine kinase (CK), Creatinine (Creat), Ferritin (Ferr), Gamma glutamyl transferase (GGT), Glucose (Glu), Glycated Hemoglobin (Hgb A1C), Iron, Lactate dehydrogenase (LDH), Magnesium (Mg), Phosphorus (Phos), Potassium (K), Sodium (Na), Prostate Specific Antigen (PSA), Total protein (TP), Triglyceride (Trig), Blood Urea Nitrogen (BUN), Uric acid (UA), and Vitamin B12 for 2 out of 3 testing events in 2025 and 2026. Findings included: Review of the laboratory's API proficiency testing (PT) records review of the CMS CASPER 153 and 155 reports, and email communication with the API PT program, the laboratory failed to successfully participate in the Subspecialty of Routine Chemistry for the analytes of Routine Chemistry, Alanine aminotransferase (ALT), Albumin (ALB), Alkaline phosphatase (Alk Phos), Amylase (Amy), Aspartate aminotransferase (AST), Total bilirubin (T Bili), Total Calcium (Ca), Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Chloride (Cl), Total Cholesterol (Chol), High density lipoprotein cholesterol (HDL), Low density lipoprotein direct measure cholesterol (LDL), Creatine kinase (CK), Creatinine (Creat), Ferritin (Ferr), Gamma glutamyl transferase (GGT), Glucose (Glu), Glycated Hemoglobin (Hgb A1C), Iron, Lactate dehydrogenase (LDH), Magnesium (Mg), Phosphorus (Phos), Potassium (K), Sodium (Na), Prostate Specific Antigen (PSA), Total protein (TP), Triglyceride (Trig), Blood Urea Nitrogen (BUN), Uric acid (UA), and Vitamin B12 1. Event #2 2025 Routine Chemistry- 0% ALT- 0% ALB- 0% Alk Phos- 0% Amy- 0% AST- 0% T Bili-0% Ca- 0% CO2- 0% CEA- 0% Cl- 0% Chol- 0% HDL- 0% LDL- 0% CK- 0% Creat- 0% Ferr- 0% GGT- 0% Glu- 0% Hgb A1C- 0% LDH- 0% Mg- 0% Phos- 0% K- 0% Na- 0% PSA- 0% TP- 0% Trig- 0% BUN- 0% UA- 0% Vitamin B12- 0% 2. Event #1 2026 Routine Chemistry- 0% ALT- 0% ALB- 0% Alk Phos- 0% Amy- 0% AST- 0% T Bili-0% Ca- 0% CO2- 0% CEA- 0% Cl- 0% Chol- 0% HDL- 0% LDL- 0% CK- 0% Creat- 0% Ferr- 0% GGT- 0% Glu- 0% Hgb A1C- 0% LDH- 0% Mg- 0% Phos- 0% K- 0% Na- 0% PSA- 0% TP- 0% Trig- 0% BUN- 0% UA- 0% Vitamin B12- 0% D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the API PT program, the laboratory failed to successfully participate in the Subspecialty of Endocrinology for the following analytes of Endocrinology, Folate, Free thyroxine (Free T4), Parathyroid Hormone (PTH), Triiodothyronine uptake (T3 Uptake), Testosterone (Test), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Thyroxine (T4) for 2 out of 3 testing events in 2025 and 2026. Findings included: Review of the API proficiency testing records and the review of the CMS 153 and 155 reports, and email communication with the API PT program, the laboratory failed to successfully participate in the Subspecialty of Endocrinology for the analytes of Endocrinology, Folate, Free thyroxine (Free T4), Parathyroid Hormone (PTH), Triiodothyronine uptake (T3 Uptake), Testosterone (Test), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Thyroxine -- 3 of 5 -- (T4) for 2 out of 3 testing events in 2025 and 2026. 1. Event #2 2025 Endocrinology- 0% Folate- 0% Free T4- 0% PTH- 0% T3 Uptake- 0% Test- 0% T3- 0% TSH- 0% T4- 0% 2. Event #1 2026 Endocrinology- 0% Folate- 0% Free T4- 0% PTH- 0% T3 Uptake- 0% Test- 0% T3- 0% TSH- 0% T4- 0% D2118 TOXICOLOGY CFR(s): 493.845(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the API PT program, the laboratory failed to successfully participate in the Subspecialty of Toxicology for the following analytes of Toxicology, and Digoxin (Dig) for 2 out of 3 testing events in 2025 and 2026. Findings included: Review of the API proficiency testing records and the review of the CMS 153 and 155 reports, and email communication with the API PT program, the laboratory failed to successfully participate in the Subspecialty of Toxicology for the following analytes of Toxicology and Digoxin (Dig) for 2 out of 3 testing events in 2025 and 2026. 1. Event #2 2025 Toxicology- 0% Dig- 0% 2. Event #1 2026 Toxicology- 0% Dig- 0% 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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the API PT program, the Laboratory Director failed to ensure the laboratory performed PT in such a manner as to achieve and maintain satisfactory performance with successful PT in the Subspecialty of Routine Chemistry for the analytes of Routine Chemistry, Alanine aminotransferase(ALT), Albumin (ALB), Alkaline phosphatase (Alk Phos), Amylase (Amy), Aspartate aminotransferase (AST), Total bilirubin (T Bili), Total Calcium (Ca), Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Chloride (Cl), Total Cholesterol (Chol), High density lipoprotein cholesterol (HDL), Low density lipoprotein direct measure cholesterol (LDL), Creatine kinase (CK), Creatinine (Creat), Ferritin (Ferr), Gamma glutamyl transferase (GGT), Glucose (Glu), Glycated Hemoglobin (Hgb A1C), Iron, Lactate dehydrogenase (LDH), Magnesium (Mg), Phosphorus (Phos), Potassium (K), Sodium (Na), Prostate Specific Antigen (PSA), Total protein (TP), Triglyceride (Trig), Blood Urea Nitrogen (BUN), Uric acid (UA), and Vitamin B12; in the Subspecialty of Endocrinology for the following analytes of Endocrinology, Folate, -- 4 of 5 -- Free thyroxine (Free T4), Parathyroid Hormone (PTH), Triiodothyronine uptake (T3 Uptake), Testosterone (Test), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Thyroxine (T4); and in the Subspecialty of Toxicology for the following analytes of Toxicology, and Digoxin (Dig) for 2 out of 3 testing events in 2025 and 2026, resulting in initial unsuccessful PT participation (See D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the API PT program, the Laboratory Director failed to ensure the laboratory performed PT in such a manner as to achieve and maintain satisfactory performance with successful PT in the Subspecialty of Routine Chemistry for the analytes of Routine Chemistry, Alanine aminotransferase(ALT), Albumin (ALB), Alkaline phosphatase (Alk Phos), Amylase (Amy), Aspartate aminotransferase (AST), Total bilirubin (T Bili), Total Calcium (Ca), Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Chloride (Cl), Total Cholesterol (Chol), High density lipoprotein cholesterol (HDL), Low density lipoprotein direct measure cholesterol (LDL), Creatine kinase (CK), Creatinine (Creat), Ferritin (Ferr), Gamma glutamyl transferase (GGT), Glucose (Glu), Glycated Hemoglobin (Hgb A1C), Iron, Lactate dehydrogenase (LDH), Magnesium (Mg), Phosphorus (Phos), Potassium (K), Sodium (Na), Prostate Specific Antigen (PSA), Total protein (TP), Triglyceride (Trig), Blood Urea Nitrogen (BUN), Uric acid (UA), and Vitamin B12 (See D2096); in the Subspecialty of Endocrinology for the following analytes of Endocrinology, Folate, Free thyroxine (Free T4), Parathyroid Hormone (PTH), Triiodothyronine uptake (T3 Uptake), Testosterone (Test), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Thyroxine (T4) (See D2107); and in the Subspecialty of Toxicology for the following analytes of Toxicology, and Digoxin (Dig) (See D2118) for 2 out of 3 testing events in 2025 and 2026, resulting in initial unsuccessful PT participation. -- 5 of 5 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Medical Specialists of the Palm Beaches Inc on August 19 to August 21, 2025. The laboratory was not in compliance with 42 CFR, Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to document incubation time in and time out for urine culture testing from October 2023 to August 19, 2025, before patient testing. Findings Include: 1. Review of Urine culture Procedure created on 7/20/22 read, "incubate plates aerobically at 35-37 Celsius (C) for 18 -24 hours (H)." 2. Review on incubation log revealed no documentation of time in and time out for urine culture testing from October 2023 to August 19, 2025. 3. Review of Urine Culture Log Form revealed 331 patients were tested for urine culture from June 3, 2025 to August 19, 2025. 4. On 8/20/2025 at 5:00 PM, the Laboratory Director confirmed there was no documentation of incubation time in and time out for urine culture testing from October 2023 to August 19, 2025. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the laboratory failed 3 out 3 patients who were tested for international normalized ratio (INR), Prothrombin Time (PT/Protime), and APTT (Activated Partial Thromboplastin Time) with expired coagulation blood tubes. Findings include: 1. On 8/19/25 at 12:36 PM, the phlebotomy area had 12 Coagulation Sodium Citrate 3.2% that had expired on 8/01 /25. Observation of the specimen's refrigerator revealed the following: a. Patient 1's specimen was collected on 8/13/25 with Coagulation Sodium Citrate 3.2% that had expired on 8/01/25. b. Patient 2's specimen was collected on 8/14/25 with Coagulation Sodium Citrate 3.2% that had expired on 8/01/25. c. Patient 3's specimen was collected on 8/14/25 with Coagulation Sodium Citrate 3.2% that had expired on 8/01 /25. 2. Review of Patient Reports revealed the following: a. Patient 1's specimen was collected on 8/13/25 at 3:34 PM, and tested on 8/14/25 at 8:58 AM, for Protime, INR and APTT. b. Patient 2's specimen was collected on 8/14/25 at 8:09 AM, and tested on 8/14/25 at 1:41 PM, for Protime, INR and APTT. c. Patient 3's specimen was collected on 8/14/25 at 9:30 AM, and tested on 8/14/25 at 1:43 PM, for Protime, INR and APTT. 3. Review of Quality Management Plan created on 7/15/22 revealed there was no policy for expired reagents and blood specimen tubes. 4. On 8/20/25 at 5:00 PM, the Laboratory Director confirmed the laboratory failed 3 out 3 patients who were tested for Protime, INR and APTT with expired coagulation blood tubes. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (1) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. This STANDARD is not met as evidenced by: Based on interview, and record review, the laboratory failed to document and identify positive and negative reactivity before patient testing for each batch of media used in urine culture testing from October 2023 to August 19, 2025. Findings Include: 1. Review of Urine Culture Procedure approved on July 20, 2022 read, "Two levels of controls are performed on each new shipment of media before patient testing occurs. Results are recorded in the media culture quality control (QC) folder and reviewed by Lab Manager." 2. Review of Quality Assurance log sheet read, "Accepting a Batch: Presence of this QC sticker indicates that all relevant quality control has been performed (Note: Mueller Hinton, all QC products, and all discs must have additional on-site performance tests)." 3. Review of Quality Assurance Log Sheet revealed no identification on what was used as a negative control, positive control and blood agar media in batches and if controls passed from October 2023 to August 19, 2025. 4. Review of Urine Culture Log Form revealed 331 patients were tested for urine culture from June 3, 2025 to August 19, 2025. 5. On August 20, 2025 at 5:00 PM, the Laboratory Director confirmed there was no documentation to identify positive and -- 2 of 3 -- negative reactivity before patient testing, for each batch of media used in urine culture testing from October 2023 to August 19, 2025. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 05/26/21 to 05/28/21 at Medical Specialists of the Palm Beaches. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. Based on the survey findings, an Immediate Jeopardy situation was identified, and the laboratory was notified at 2:00 PM on 05/28/2021. The laboratory failed to follow manufacturers' instructions for specimen storage (See D5300) and failed to validate a non-FDA approved COVID-19 test kit prior to patient testing (See D5400). The following Condition was not met: D5300- Preanalytic Systems-493.1240 D5400-Analytic Systems-493.1250 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of records and interview the laboratory failed to maintain temperature records and microbiology quality control documentation for 1 (2020) out of 2 years (2020-2021) reviewed. Findings Included: Review of temperature logs for the lab revealed that there were no records from 2020. Review of Microbiology quality control logs revealed that there were no records from 2020. Interview on 05/26/21 at 4: 00 PM the Laboratory Director confirmed that the temperatures and Microbiology quality control were documented, however the logs could not be located. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director the laboratory failed to have competency evaluations for the Clinical Consultant for 2 (2019-2021) out of 2 years reviewed. Findings Included: Review of employee competencies revealed no competencies performed on the Clinical Consultant. Interview on 05/27 /21 at 1:11 PM the Laboratory Director confirmed that there were no competency evaluations performed on the Clinical Consultant. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Director the laboratory failed to follow manufacturer's instructions (MI) for specimen storage on the Lugene COVID-19 IgG/IgM Rapid test cassette kit (unvalidated) since testing began June 2, 2020 (See D5311). D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director the laboratory failed to follow manufacturer's instructions (MI) for specimen storage on the Lugene COVID-19 IgG/IgM Rapid test cassette kit (unvalidated) since testing began June 2, 2020. The findings included: Review of Lugene COVID-19 IgG/IgM Rapid test cassette kit MI the specimen should be tested immediately or stored at 2-8 degrees Celsius for 3 days maximum and if longer than 3 days the stored at -20 degrees Celsius. Review of 10 random Patient test reports revealed the following: Patient #1-- tested 03/25/21 was drawn at 12:50 PM and ran at 4:48 PM (3 hours and 58 minutes) Patient #2--tested 03/25/21 was drawn at 2:26 PM and ran at 5:23 PM (2 hours 57 minutes) Patient #3--tested 04/23/21 was drawn at 12:27 PM and ran at 1:28 PM (1 hour and 1 minutes) Patient #4--tested 04/26/21 was drawn at 1:15 PM and ran at 4:05 PM (2 hours and 50 minutes) Patient #5--tested 05/19/21 was drawn at 12:32 PM and ran at 1:07 PM (35 minutes) Patient #6--tested 03/25/21 was drawn at 2:45 PM and -- 2 of 4 -- ran at 5:02 PM (2 hours and 17 minutes) Patient #7--tested 03/25/21 was drawn at 2: 53 PM and ran at 5:01 PM (2 hours and 8 minutes) Patient #8--tested 05/10/21 was drawn at 10:43 AM and ran 3:10 PM (4 hours and 27 minutes) Patient #9--tested 05/11 /21 was drawn at 1:03 PM and ran 3:10 PM (2 hours and 7 minutes) Patient #10-- tested 05/11/21 was drawn at 1:03 PM and ran at 3:11 PM (2 hours and 8 minutes) Interview on 05/27/21 at 12:55 PM the Laboratory Director revealed that after the specimens are placed in a rack on the counter after drawn and ran when the tech or the phlebotomists have time to run them, confirming that the tests are not ran immediately. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Director the laboratory failed to validate the Lugene COVID-19 IgG/IgM Rapid test cassette kit since starting testing on 06/02/2020. There were 2,238 patients tested. (See D5423) 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 record review and interview with the Laboratory Director the laboratory failed to validate the Lugene COVID-19 IgG/IgM Rapid test cassette kit since starting testing on 06/02/2020. There were 2,238 patients tested. The findings included: Review of the Manufacturer's Instructions for the Lugene COVID-19 IgG/IgM Rapid test cassette kit revealed that the test is not FDA approved. Review of the FDA website revealed that there is no EUA for this antibody test kit. This would make the Lugene COVID-19 IgG/IgM Rapid test cassette kit a Laboratory Developed Test and would need a validation. There was no validation of this test kit. Interview on 05/26 /21 at 5:00 PM the Laboratory Director confirmed that the test kit had not been validated and that all testing would stop on 05/26/21. -- 3 of 4 -- 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, record review, and interview the laboratory failed to calibrate 1 out of 1 timer and failed to have incubator temperatures that were within the acceptable range on 47 out of 100 days in 2021. Findings Included: Observations taken during the tour of the laboratory on 05/26/21 at 11:22 PM revealed a timer with a sticker on the back that said the next calibration was due 07/27/07. Review of preventative maintenance revealed no calibrations for the timer. Interview on 05/26 /21 at 1:39 PM the Laboratory Director confirmed that no calibrations had been performed on the timer. Review of the manufacturer's instructions for the TSA 5% Sheep Blood/ MacConkey Agar Biplate (used for urine cultures) revealed that the incubation temperature soul be 33-37 degrees Celsius. Review of the temperature logs revealed that the temperature was not acceptable on 01/07/21 (38), 02/17/21 (38), 02 /24/21 (38), 03/04/21 (38), 03/05/21 (38), 03/08/21 (38), 03/09/21 (38), 03/10/21 (38), 03/11/21 (38), 03/12/21 (38), 03/22/21 (38), 03/23/21 (38), 03/24/21 (38), 03/26/21 (38), 03/29/21 (38), 03/30/21 (38), 03/31/21 (38), 04/01/21 (38), 04/02/21 (38), 04/05 /21 (39), 04/06/21 (38), 04/09/21 (38), 04/12/21 (38), 04/13/21 (38), 04/14/21 (38), 04 /19/21 (38), 04/20/21 (38), 04/21/21 (38), 04/26/21 (38), 04/27/21 (38), 04/28/21 (38), 04/29/21 (38), 05/03/21 (39), 05/04/21 (38), 05/05/21 (38), 05/06/21 (39), 05/07/21 (38), 05/10/21 (39), 05/12/21 (38), 05/13/21 (38), 05/14/21 (38), 05/19/21 (38), 05/20 /21 (38), 05/21/21 (38), 05/24/21 (38), 05/25/21 (38), and 05/26/21 (38). Interview on 05/27/21 at 2:30 PM the Laboratory Director confirmed that the temperature range on the incubator was not acceptable and that there was no