Ohio Valley Health Center

Summary Statement of Deficiencies 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 an interview with Testing Personnel (TP) #1, the laboratory failed to establish and follow written policies and procedures for specimen acceptability and rejection of blood specimens collected for complete blood count (CBC) testing, prostate specific antigen (PSA) testing, thyroid-stimulating hormone (TSH) testing, and Vitamin D testing. This deficient practice had the potential to affect 363 out of 363 patients tested under the specialties of Hematology and Chemistry, and the subspecialty of Endocrinology from 08/29/2023 through 12/29 /2024. Findings Include: 1. Review of the laboratory's "Ohio Valley Health Center" policies and procedures, unapproved by the Laboratory Director, and provided on the date of inspection, did not find any mention of policies or procedures for specimen acceptability and rejection of blood specimens collected for CBC, PSA, TSH and Vitamin D testing. 2. The inspector requested policies and procedures for specimen acceptability and rejection of blood specimens collected for CBC, PSA, TSH and Vitamin D testing from TP #1. TP #1 confirmed the laboratory did not include specimen acceptability and rejection in their policies and procedures and did not have any documentation to provide on the date of the inspection. The interview occurred on 12/29/2024 at 10:40 AM. D5807 TEST REPORT 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 -- CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to report the correct Alkaline Phosphatase (ALP), Glucose (GLU), and Potassium (K+) reference range values for two out of two patient test reports reviewed. This deficient practice had the potential to affect 45 out of 45 patients tested in the subspecialty of Routine Chemistry from 11/01/2024 through 12/30/2024. Findings include: 1. Review of the laboratory's "Comprehensive Metabolic Panel by Abaxis Piccolo Xpress" policy and procedure unapproved by the laboratory director via signature and date, and provided on the date of inspection found the following: Analyte Male Range ALP (U/L) 53 - 128 Analyte Range GLU (mg/dL) 73 - 118 K+ (mmol/L) 3.6 - 5.1 2. Review of two chemistry test reports found the following reference ranges listed: Date DOB Reference Range 11/7/2024 5/21/1980 GLU 73- 100 mg/dL K+ 3.6-5.3 mmol/L ALP 3.6-5.3 mmol/L Date DOB Reference Range 12 /10/2024 7/27/1970 GLU 73-100 mg/dL K+ 3.6-5.3 mmol/L 3. An interview with TP #1, confirmed the ALP, GLU, and K+ reference ranges listed in the policy and procedure did not match the reference ranges listed on the patient reports. The interview occurred 12/29/2024 at 1215 PM. U/L = units per liter mg/dL = milligrams per deciliter mmol/L = millimoles per liter 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 record review and an interview with Testing Personnel (TP) #1, the Laboratory Director failed to ensure that the Vitamin D test accuracy verification (TAV) activities were conducted as required under subpart H of this part. There were no patients tested for Vitamin D from 05/23/2024 through 09/03/2024. Findings Include: 1. Review of the "Quality Management Policy" unapproved by the Laboratory Director, did not find any mention of the frequency for testing proficiency samples. 2. Review of the laboratory's 2024 American Proficiency Institute (API) Chemistry 3rd event documentation, provided on the date of the inspection, revealed a score of 0%. Further review found the following statement: "No Vitamin D testing performed during the testing period. Will resume when testing resumes." 3. TP#1 stated the laboratory did not perform any patient Vitamin D tests from 05/23/2024 through 09/03/2024, did not complete the API Chemistry 3rd event, and disposed of the samples upon receipt. The interview occurred on 12/30/2024 at 10:30 AM. D6031 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 an interview with Testing Personnel (TP) #1, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of complete blood count (CBC) testing, prostate specific antigen (PSA) testing, thyroid-stimulating hormone (TSH) testing, and Vitamin D testing procedures performed in the specialties of Hematology and Chemistry, and the subspecialty of Endocrinology. This deficient practice had the potential to affect 45 out of 45 patients tested from 11/01/2024 through 12/29/2024. Findings Include: 1. Review of the laboratory's "Ohio Valley Health Center" policies and procedures, did not find the Laboratory Director's approval via signature and date. 2. The inspector requested approved policies and procedures for any aspect of CBC testing, PSA testing, TSH testing, and Vitamin D testing procedures from TP #1 . TP #1 stated the Laboratory Director did not approve the new policies and procedures via signature and date, and was unable to provide the requested information. The interview occurred on 12/29/2024 at 10:15 AM. -- 3 of 3 --

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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to enroll in a proficiency testing (PT) program for the specialty of Hematology and the subspecialty of Endocrinology. This deficient practice had the potential to affect 53 patients tested under the specialty of Hematology and 15 patients tested under the subspecialty of Endocrinology from 03/13/2023 through 08/29/2023. Findings Include: 1. The laboratory failed to enroll in a PT program for the specialty of Hematology and the subspecialty of Endocrinology. (Refer to D2001) D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; 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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to enroll in a proficiency testing (PT) program for the specialty of Hematology and the subspecialty of Endocrinology. This deficient practice had the potential to affect 53 patients tested under the specialty of Hematology and 15 patients tested under the subspecialty of Endocrinology from 03/13/2023 through 08/29/2023. Findings Include: 1. Review of the laboratory's "Proficiency Testing Policies" policy and procedure, approved via signature and date by the Laboratory Director on 02/21 /2023, found the following statement: "QA Manual FastPack IP System Quality Assurance Manual ...This laboratory enrolls annually in PT for all non-waived tests, such as the FastPack IP System tests." 2. The inspector asked for the 2023 PT records for Hematology and Endocrinology from TP #1. 4. TP #1 confirmed the laboratory was not enrolled with an HHS approved PT provider for the specialty of Hematology and the subspecialty of Endocrinology and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 08/29/2023 at 11:00 AM. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on direct observation and an interview with Testing Personal (TP) #1, the laboratory failed to establish safety procedures which ensured protection from chemical and biological hazards. This deficient practice had the potential to affect all personnel in or near the laboratory. Findings Include: 1. Document review did not find any chemical and biological spill procedures, or disposition of chemical and biological waste procedures available to facility personnel. 2. Direct observation in the laboratory revealed a Sysmex XP-300 analyzer with a CellPack reagent container connected and next to the instrument. Review of the material safety data sheet (MSDS) found the following statements: "6 Accidental release measures Ensure adequate ventilation. For large spills, wear protective clothing. For large spills, use respiratory protective device against the effects of fumes/dust/aerosol. Environmental precautions Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage system. Methods and material for containment and cleaning up Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Send for recovery or disposal in suitable receptacles." 3. Further observation revealed a red sharps biohazard disposal container on the counter next to a patient blood draw chair. 4. TP #1 stated patient blood draws and urine testing were performed in the same laboratory as the Sysmex instrument testing. The inspector requested safety policies and procedures, chemical and biological spill kits, and an eye wash station from TP #1. TP #1 confirmed the laboratory did not have safety policies and procedures, chemical and biological spill kits, or an eye wash station. The interview occurred on 08/29/2023 at 1:30 PM. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) -- 2 of 4 -- 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 an interview with Testing Personnel (TP) #1, the laboratory failed to establish and follow written policies and procedures for specimen acceptability and rejection of blood specimens collected for complete blood count (CBC) testing and thyroid-stimulating hormone (TSH) testing. This deficient practice had the potential to affect 53 patients tested under the specialty of Hematology and 15 patients tested under the subspecialty of Endocrinology from 03/13/2023 through 08 /29/2023. Findings Include: 1. Review of the laboratory's "QA Manual FastPack IP System" quality assurance manual provided to the laboratory by the manufacturer, approved via signature and date by the Laboratory Director on 02/21/2023, did not find any mention of policies or procedures for specimen acceptability and rejection of blood specimens collected for CBC testing and TSH testing. 2. The inspector requested policies and procedures for specimen acceptability and rejection of blood specimens collected for CBC testing and TSH testing from TP #1. TP #1 confirmed there was no policy or procedure, or documentation for specimen acceptability and rejection. The interview occurred on 08/29/2023 at 11:30 AM. 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 record review, direct observation and an interview with Testing Personnel (TP) #1, the laboratory failed to have a written procedure manual for complete blood count (CBC) testing. This deficient practice had the potential to affect 53 patients tested under the specialty of Hematology from 03/13/2023 through 08/29/2023. Findings include: 1. Review of the form CMS-116 section VIII found the speciality of Hematology marked as being performed.. 2. Direct observation found a Sysmex XP- 300 blood analyzer in the laboratory. 3. The inspector requested a written procedure manual for the complete blood count testing from TP #1. TP #1 confirmed there was no written procedure manual for the Sysmex XP-300 procedures and was unable to provide the requested documentation. The interview occurred on 08/29/2023 at 1:15 PM. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personal (TP) #1, the laboratory failed to document all assessment activities of an ongoing mechanism to monitor, assess, and correct problems identified in the post analytic systems. This deficient practice had the potential to affect 53 patients tested under the specialty of Hematology and 15 patients tested under the subspecialty of Endocrinology from 03 /13/2023 through 08/29/2023. Findings Include: 1. Review of the "Quality Assurance Assessment Program" signed and dated by the Laboratory Director on 02/21/2023 found no mention of documenting assessment activities of an ongoing mechanism to monitor, assess, and correct problems identified in the post analytic systems. 2. Further document review did not find any written assessment activities of an ongoing mechanism to monitor, assess, and correct problems identified in the post analytic systems. 3. The inspector requested post analytic quality assurance documentation from TP #1. TP #1 stated the post analytic assessment activities were completed but not documented and was unable to provide the requested information. The interview occurred on 08/29/2023 at 1:45 PM. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the Technical Consultant (TC) failed to evaluate and document the competency of one out of one Testing Personnel (TP) in 2023 assuring their competency was maintained in order to perform moderately complex complete blood count (CBC) and automated differential (Adiff) testing in the specialty of Hematology, and report the test results promptly, accurately, and proficiently. This deficient practice had the potential to affect 53 out of 53 patient CBC and Adiff tests conducted from 03/13/2023 through 08 /29/2023. Findings Include: 1. Review of the laboratory's form CMS-209 found one out of one individual listed, credentialed and approved by the Laboratory Director via signature and date on 08/10/2023 to function in the role of TP for moderate complexity testing. 2. Review of the laboratory's 2023 competency assessment documentation, provided on the date of inspection, did not find any competency assessments completed for CBC testing. 3. The inspector requested the competency assessment policies and procedures, and the 2023 CBC competency assessment records for TP #1 from TP #1. 4. TP #1 confirmed there was no CBC competency policy or procedure, competency assessments were not conducted for CBC testing, and could not provide the requested documents. The interview occurred on 08/29 /2023 at 10:35 AM. -- 4 of 4 --